Adjustable lancet and test cartridge for automated medical sample collection and testing

ABSTRACT

A test cartridge includes an adjustable lancet. The adjustable lancet is controlled by a controller. The adjustable lancet automatically detects a subject&#39;s finger, adjusts the lancet&#39;s height, pricks the finger to draw blood, moves a tube to collect the blood, moves the tube away from the finger, and empties the blood from the tube into a vial or receptacle. The adjustable lancet may include safety features to prevent the lancet to trigger when the subject&#39;s fingernail is facing the lancet, to control the amount that the lancet pierces the subject&#39;s finger, and/or to prevent the reuse of a test cartridge for multiple persons or multiple times by the same person. The adjustable lancet may include a massager wheel and/or a pressure bar to rub the subject&#39;s finger after the finger is pierced to facilitate drawing of the blood from the finger.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. patentapplication Ser. No. 16/663,711, filed on Oct. 25, 2019, published asU.S. Patent Publication 2020/0054260. U.S. patent application Ser. No.16/663,711 is a continuation-in-part of U.S. patent application Ser. No.15/959,555, filed Apr. 23, 2018, published issued as U.S. Pat. No.11,103,163. U.S. patent application Ser. No. 15/959,555 is acontinuation-in-part of U.S. patent application Ser. No. 15/954,442,filed on Apr. 16, 2018, issued as U.S. Pat. No. 10,791,972. U.S. patentapplication Ser. No. 15/954,442 is a continuation-in-part of U.S. patentapplication Ser. No. 15/785,755, filed on Oct. 17, 2017, issued as U.S.Pat. No. 10,928,411. U.S. patent application Ser. No. 15/785,755 claimspriority to U.S. Provisional Patent Application Ser. No. 62/488,174,filed on Apr. 21, 2017. The contents of U.S. patent application Ser. No.16/663,711 published as U.S. Patent Publication 2020/0054260 and U.S.patent application Ser. No. 15/959,555, issued as U.S. Pat. No.11,103,163, are hereby incorporated by reference.

BACKGROUND

Many users, whether professional or home-based, may wish to take bloodsamples (and/or other fluid samples) on a regular basis. For instance,people with type I diabetes may need to measure blood sugar at leastfour times per day.

Existing sampling methods require users to manually prick a fingertip togenerate and collect a sample for testing. Such sampling results ininconsistent sample quantities, stress and anxiety for the subject,potential for sample contamination, and/or other issues related tomanual collection and processing. In addition, even current lancingdevices require a user to manually align the device and lancet. A useralso has to manually specify desired device parameters, such asextension force.

Furthermore, after generating a sample, a subject may need to performadditional operations such as collecting the sample, applying the sampleto a test strip, inserting the strip into a testing device, etc.

In addition, as collection may be performed frequently, subjects maywish to collect the minimum sample needed for testing.

When conducting trials or otherwise collecting samples, currentsolutions require a significant time commitment for each subject (e.g.,fifteen minutes or to draw a sample, perform a test, collectmeasurements, etc.).

Thus there is a need for a way to automatically and quickly generate andcollect a sample for testing with accurate and controllable lancetalignment and extension.

SUMMARY

A sample collection and testing device (SCTD) of some embodiments may beable to collect a sample from a test subject. The SCTD may utilizeremovable cartridges. Such cartridges (or portions thereof) may beintended for single use.

Some embodiments are able to automatically collect a blood sample from asubject's finger. Such sample collection may involve detection of thesubject (or finger in this example), piercing or pricking of thesubject, collection, and/or storage of the sample. Although blood isused as one example, various other fluids may be collected and/oranalyzed.

The sample may be collected via a receptacle (e.g., a recess in asurface of the cartridge) using a pump, valve, fluid sensing chip,tubing or other flow pathways, storage cavities, and/or otherappropriate features.

A piercing element of some embodiments may include a needle and spring,actuator, and/or other appropriate elements. The piercing element may beautomatically extended an appropriate amount to draw blood through theskin in this example. The amount of extension may be specified and/orlimited in various appropriate ways (e.g., physical or mechanicalbarriers or stops, a value associated with the actuator extension,etc.). The extension may be set by a user, may be based on defaultvalues, or may be determined automatically using various sensorsassociated with the SCTD and/or cartridge.

A disposable cartridge of some embodiments may include a top plate, amicrofluidic chip, a bottom plate, and a removable top cover. The topcover may be removed to provide access to the cartridge (e.g.,collection points) and replaced to secure the contents for disposal. Thebottom plate may include a lancet assembly. The lancet assembly mayinclude a spring, lancet, lancet cup, and actuator receptacle. Thebottom plate may include a lancet guide.

In some embodiments, a fluid sensing device (and/or other elements ofthe cartridge) may include and/or be at least partially enclosed in aflexible material (e.g., silicone). Such enclosed elements may come intocontact with the sample fluid and thus be intended to be single use ordisposable. Other elements, such as the piercing element, that come intocontact with the sample fluid may also be included in a disposablecartridge (or disposable portion thereof). Throughout the specification,any reference to “disposable” elements or components indicates singleuse components (e.g., components that will directly contact a bloodsample).

Some embodiments may include non-contact sensing elements such that thefluid sensing device is able to be reused. Such non-contact elements mayinclude, for instance, embedded sensors or leads that are able to beaccessed via terminals along an outer surface of the cartridge. In someembodiments, the sensing elements may be able to sense properties of thesample through the enclosure without use of any exposed leads orcontacts.

The non-contact elements may include fluid measurement features in someembodiments. The fluid measurement features may include opticalmeasurement elements that are able to detect and measure propertiesassociated with fluid samples. Such measurements may include, forexample, volume, viscosity or flow rate, color density or saturation,etc.

One example cartridge may be able to perform a test for cancer usinghuman aspartyl (asparaginyl) β-hydroxylase (HAAH) protein and itsassociated antibodies. Such a cartridge may utilize magnetic beads andcharge detection to evaluate samples.

Some embodiments of the SCTD (and/or associated cartridges) may be ableto measure small amounts of fluid using optical components such aslasers, light-emitting diode (LED) lights sources, and/or other opticalcomponents to detect fluid within a transparent or semi-transparentfluid pathway.

The preceding Summary is intended to serve as a brief introduction tovarious features of some exemplary embodiments. Other embodiments may beimplemented in other specific forms without departing from the scope ofthe disclosure.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The exemplary features of the disclosure are set forth in the appendedclaims. However, for purpose of explanation, several embodiments areillustrated in the following drawings.

FIG. 1 illustrates a top view of an automated sample collection andtesting device according to an exemplary embodiment;

FIG. 2 illustrates a front elevation view of the automated samplecollection and testing device of FIG. 1;

FIG. 3 illustrates a side elevation view of an exemplary embodiment of asample processing module included in the sample collection and testingdevice of FIG. 1;

FIG. 4 illustrates a side elevation view of another exemplary embodimentof the sample processing module included in the sample collection andtesting device of FIG. 1;

FIG. 5 illustrates a side elevation view of an exemplary embodiment of acartridge used by the sample collection and testing device of FIG. 1;

FIG. 6 illustrates a top plan view of the exemplary cartridge of FIG. 5;

FIG. 7 illustrates a bottom plan view of the exemplary cartridge of FIG.5;

FIG. 8 illustrates a side elevation view of the exemplary cartridge ofFIG. 5, including an exploded view of an exemplary lancet;

FIG. 9 illustrates a side elevation view of an exemplary embodiment of alancet actuator included in the sample collection and testing device ofFIG. 1;

FIG. 10 illustrates a side elevation view of the lancet actuator of FIG.9 in an extended position;

FIG. 11 illustrates a top plan view of the lancet actuator of FIG. 9;

FIG. 12 illustrates a bottom plan view of the lancet actuator of FIG. 9;

FIG. 13 illustrates a schematic block diagram of a system including theautomated sample collection and testing device of FIG. 1;

FIG. 14 illustrates a schematic block diagram of a cartridge interfaceincluded in the automated sample collection and testing device of FIG.1;

FIG. 15 illustrates a schematic block diagram of a cartridge used by theautomated sample collection and testing device of FIG. 1;

FIG. 16 illustrates a schematic block diagram of an exemplary embodimentof the sample processing module included in the sample collection andtesting device of FIG. 1;

FIG. 17 illustrates a schematic block diagram of a second exemplaryembodiment of the sample processing module included in the samplecollection and testing device of FIG. 1;

FIG. 18 illustrates a schematic block diagram of a third exemplaryembodiment of the sample processing module included in the samplecollection and testing device of FIG. 1;

FIG. 19 illustrates a partial side view of a sample processing moduleaccording to an exemplary embodiment;

FIG. 20 illustrates a partial top view of a sample processing moduleaccording to an exemplary embodiment;

FIG. 21 illustrates a side elevation view of an optical measurementelement according to an exemplary embodiment;

FIG. 22 illustrates a schematic block diagram of an optical measurementelement according to an exemplary embodiment;

FIG. 23 illustrates a schematic block diagram of various opticalprocessing components associated with an optical measurement element insome embodiments;

FIG. 24 illustrates a top plan view of a portion of a cartridgeassociated with an optical measurement element in some embodiments;

FIG. 25 illustrates a side elevation view of a portion of a cartridgeassociated with an optical measurement element in some embodiments;

FIG. 26 illustrates a flow chart of an exemplary process that collectsand tests a sample using the automated sample collection and testingdevice of FIG. 1;

FIG. 27 illustrates a flow chart of an exemplary process that collects asample using the automated sample collection and testing device of FIG.1;

FIG. 28 illustrates a flow chart of an exemplary process that controls asampling element of the automated sample collection and testing deviceof FIG. 1;

FIG. 29 illustrates a flow chart of another exemplary process thatcontrols a sampling element of the automated sample collection andtesting device of FIG. 1;

FIG. 30 illustrates a flow chart of an exemplary process that impels asmall amount of fluid within the exemplary embodiments of the sampleprocessing module included in the sample collection and testing deviceof FIG. 1;

FIG. 31 illustrates a flow chart of an exemplary process that measuresfluid parameters within the exemplary embodiments of the sampleprocessing module included in the sample collection and testing deviceof FIG. 1;

FIG. 32 illustrates a perspective view of an exemplary embodiment of anadjustable lancet assembly used by the sample collection and testingdevice of FIG. 1;

FIG. 33 illustrates a perspective view of the exemplary adjustablelancet assembly of FIG. 32 with the finger massager assembly removed;

FIG. 34 illustrates a side elevation view of the exemplary adjustablelancet assembly of FIG. 32;

FIG. 35 illustrates a side elevation view of the exemplary adjustablelancet assembly of FIG. 33;

FIG. 36 illustrates a front elevation view of an exemplary embodiment ofthe finger receptacle and the lancet housing of FIGS. 32-35;

FIG. 37 illustrates a front elevation view of the exemplary embodimentof the finger receptacle and the lancet housing of FIG. 36 when thelancet housing is lowered to touch the subject's finger.

FIGS. 38A-38B illustrate a flow chart of an exemplary process thatcontrols the adjustable lancet of FIGS. 32-37.

FIG. 39 illustrates a flow chart of an exemplary process that processesa sample using the sample processing module of FIG. 16;

FIG. 40 illustrates a flow chart of an exemplary process that processesa sample using the sample processing module of FIG. 17;

FIG. 41 illustrates a flow chart of an exemplary process that processesa sample using the sample processing module of FIG. 18; and

FIG. 42 illustrates a schematic block diagram of an exemplary computersystem used to implement some embodiments.

DETAILED DESCRIPTION

The following detailed description describes currently contemplatedmodes of carrying out exemplary embodiments. The description is not tobe taken in a limiting sense, but is made merely for the purpose ofillustrating the general principles of some embodiments, as the scope ofthe disclosure is best defined by the appended claims.

Various features are described below that can each be used independentlyof one another or in combination with other features. Broadly, someembodiments generally provide an automated sample collection and testingdevice (SCTD).

Some embodiments may include lancet assemblies that allow automaticsample generation (e.g., finger pricking) and collection. Such lancetassemblies may include a spring, lancet, actuator, various guides, etc.

A first exemplary embodiment provides a disposable lancet assemblycomprising: a spring aligned along a linear axis; a lancet aligned alongthe linear axis adjacent to the spring; a needle cup aligned along thelinear axis adjacent to the lancet; and a housing comprising a channelthat accepts an actuator interface such that the needle cup and lancetare able to be moved along the linear axis via the actuator interface.

A second exemplary embodiment provides a medical test cartridgecomprising: a bottom plate; a microfluidic chip; and a top plate,wherein the top plate is coupled to the bottom plate such that themicrofluidic chip is retained between the top plate and the bottomplate.

A third exemplary embodiment provides a sample collection and testingdevice comprising: a lancet assembly; a lancet actuator coupled to thelancet assembly; and a microfluidic test chip.

Several more detailed embodiments are described in the sections below.Section I provides a description of hardware architectures of someembodiments. Section II then describes various methods of operation ofsome embodiments. Lastly, Section III describes a computer system whichimplements some of the embodiments.

I. Hardware Architecture

FIG. 1 illustrates a top view of an automated SCTD 100 according to anexemplary embodiment. As shown, the device may include a removable testsample processing module 110, various user interface (UI) features 120,such as buttons, displays, touchscreens, keypads, LEDs, etc., and ahousing 130.

The sample processing module 110 will be described in more detail inreference to FIG. 2 below. The housing 130 may be able to sit flat on asurface such as a tabletop or counter. The housing may includereceptacles, sockets, etc. that may allow the housing to be attached tovarious elements, as appropriate (e.g., stands, carts, etc.). Thehousing may include various mechanical features (e.g., a cartridgerelease lever and associated mechanism, a hinged lid or door thatprovides access to elements within the housing, etc.).

FIG. 2 illustrates a front elevation view of the automated samplecollection and testing device 100. As shown, the sample processingmodule 110 of this example includes a receptacle 210 sized and shapedappropriately for a human finger, a bottom portion 220, a top portion230, and a disposable cartridge 240 (or cavity if no cartridge has beeninserted) that is able to be added to or removed from the sampleprocessing module 110. In this example, the top portion 230 may includea hinge such that the top portion may be pulled away from the bottomportion to expose the cartridge 240 (or cavity).

FIG. 3 illustrates a side elevation view of an exemplary embodiment ofthe sample processing module 110, showing various internal components ofthe cartridge. As shown, the cartridge may include a rubber pump 305,retention element 310, sample pump 315, pinch valve 320, chip 325,tubing or other connectors 330, an actuator 335, a receptacle 340,needle and spring 345, needle housing 350, needle connector 355, andcartridge housing 360.

In this example, elements 325-330 and 340-360 may typically be includedin the disposable cartridge portion 240 of the sample processing module110, while the other components may be included in a reusable portion ofthe sample processing module 110 or otherwise included in the SCTD 100.

The rubber pump 305 may be a device capable of pumping fluid (e.g., air)into the retention element 310. The fluid may be in a liquid and/orgaseous form. The retention element 310 may be a balloon or flexiblebladder that is able to accept an appropriate amount of fluid and, inturn, provide adjustable resistance to pressure. In some embodiments,the balloon may be coupled to a door of the housing, where the door maybe opened, an appendage inserted, and the door closed. Such a door mayinclude an electromagnetic latch.

The sample pump 315 may be a pump capable of moving fluid along apathway. In some embodiments, the sample pump may be associated with ameasurement element or meter (not shown) that is able to determine anamount of fluid moved by the pump. The pinch valve 320 may be acontrollable valve capable of permitting or restraining fluid flowwithin the sample processing module 110.

The “chip” 325 or fluid sensing plate may be able to store and/orinteract with various fluids (e.g., sample fluids, reactants, catalysts,etc.). The chip may include electronic circuitry (e.g., sensors,integrated circuits, etc.) that may be able to detect or measureattributes of the fluid(s) and generate signals that provide themeasured attributes to other components (e.g., a processor).

Some embodiments may include a fluid sensing plate that is reusableacross multiple samples. Such a plate may either contact a sampleindirectly (e.g., using disposable probes that are part of the cartridgeand are able to provide electrical connection via some externalconnectors to the device 100). In some embodiments, the plate may becompletely non-contact and sense fluid attributes through a siliconemembrane or other appropriate cartridge material.

The tubing or other connectors 330 may allow fluid flow among theelements of the sample processing module 110. In some embodiments, thetubing 330 may be formed by cavities within a solid element. Forinstance, in some embodiments, the chip 325, tubing 330, and receptacle340 may be included in cube-shaped silicone.

The actuator 335 may be able to apply force to the connector 355. Theactuator 335 may be able to extend and retract the connector 355. Theactuator 335 may include components such as a linear solenoid, a rotarymotor, etc. In some embodiments, the actuator may be controllable suchthat attributes such as depth or height, pressure, velocity,acceleration, torque, etc. may be able to be controlled based on variousparameters (e.g., default values, user selections, measured values,etc.).

The receptacle 340 may include a recess or tub appropriate for placementof a finger in this example. Different embodiments may include differentreceptacles. For instance, some embodiments may include a connector thatallows vials or other containers (e.g., micro tubes or other industrystandard micro containers) to be coupled to the sample processing module110. In some embodiments, the fluid may be collected and tested at thereceptacle 340. For instance, a droplet of blood from a fingertip may beapplied to a paper test strip located at the receptacle. In someembodiments, a micro tube or other container may be removed (after asample has been collected) and sent elsewhere for testing (or attachedto another testing device).

The extendable and retractable needle and spring 345 (or other piercingelement such as a blade) may be able to extend out into the receptacle340 such that a sample may be taken. The spring may cause the needle 345to automatically retract when pressure is released from the actuator335. The height and/or other attributes of the needle 345 may beadjusted manually or electronically (e.g., using actuators). Forinstance, some embodiments may include a physical knob that may allowusers to adjust the height of housing 350, thereby controlling themaximum extension of the needle 345.

As another example, some embodiments may allow a desired height orextension of the needle 345 to be entered using a UI element or externaldevice. Such desired height may be set in relative (e.g., discretevalues from one to ten) or absolute terms (e.g., height in millimeters).The desired height may be used to control the operation of the actuator335 to control the extension of the needle 345. Some embodiments mayinclude various sensors that may automatically determine a desiredheight and apply such determined height to the operation of the needle345. Such adjustment parameters may be stored such that a user maycollect additional samples once comfortable needle use has beenachieved.

The needle housing 350 may be a rigid hollow column. In this example,the housing is associated with a round needle and spring 345 and acylindrical connector 355. Different embodiments may have elements withdifferent shapes, based on the particular application.

The needle connector 355 may be a rigid member that couples the actuator335 to the needle 345 such that the extension (or retraction) of theactuator 335 causes the needle 345 to be extended (or retracted).

The cartridge housing 360 in this example has a cube shape. The housingmay include multiple portions. Some embodiments may include hinges,latches, etc. that may couple the portions. The housing may includevarious interfaces for use with the SCTD 100. Such interfaces mayinclude, for instance, sockets or other connectors, terminals, wirelesscommunication interfaces, etc.

During use, a subject's finger may be retained using the rubber pump 305and balloon 310. The punching needle and associated spring 345 may bemanipulated by the actuator 335 via the connector 355 to pierce thesubject's finger and a blood sample may be collected using the chip 325,pinch valve 320, pump 315, and collection receptacle 340 under thefinger. In addition, various tubes, connectors, etc. 330 may be utilizedto transport fluid from the collection receptacle 340 to the chip 325.

The pressure of the balloon 310 (or other retaining element) may beadjustable. Such pressure may be set to retain the finger in placewithout causing a feeling that the finger is trapped or any otherdiscomfort. Such a pressure adjustment may utilize various appropriateUI elements, including, for instance, up/down buttons, touchscreenfeatures, received command from an external device, etc. Suchadjustments may be stored for future use by a particular subject. Thepressure may be determined (and/or controller) in various appropriateways, such as measuring (and/or varying) pump current and/or using anelectronic pressure sensor device.

In this example, the sample processing module 110 includes automatedcollection and processing. Some embodiments may be able to receive acartridge that includes a previously collected sample (e.g., held in amicrotube). Such embodiments may be able to pierce (and/or otherwiseinteract with) the microtube in order to retrieve and analyze thecollected sample.

Some embodiments may include at least one flowmeter. Such a flowmetermay follow the collection point in order to monitor the flow of fluidand/or measure volume. Such elements may be omitted in some embodimentsin order to reduce cost of the sample processing module 110 (ordisposable portions thereof).

In some embodiments, the SCTD 100 may automatically detect the fingerand activate the device. Some embodiments may include a manual controlsuch as a button or touchscreen 120 that can be used to activate thedevice 100. Such a control may be received as a command message from anexternal user device.

FIG. 4 illustrates a side elevation view of another exemplary embodimentof the sample processing module 110. In this example, the chip 410 maybe located at the sample collection point (e.g., receptacle 340 wherethe finger is placed). The chip 410 may be made from a flexible materialsuch as silicone. In such embodiments, the needle 345 may be placedbelow the chip 410 and pierce the chip 410 before pricking the finger.The material may then seal itself after the needle 345 is retracted suchthat the blood is retained within the chip or sample collection cavity410. In this example, the needle 345 is in a fully retracted positionwhereas in the example of FIG. 3, the needle was in a partially or fullyextended state.

In this example, the needle housing 350 may be split into two portions(a top portion and a bottom portion from this view), where one portion(i.e., the top portion in this example) is included in the disposableinsert 360 of some embodiments. Other components may be included in thedisposable insert, such as the needle and spring 345, the chip 410, andthe receptacle 340. As above, any electronic sensing plate may beincluded in the removable cartridge 360 along with the chip 410 or maybe included with the non-disposable components.

In the examples of FIG. 3 and FIG. 4, different embodiments may includedifferent components within the disposable cartridge of someembodiments. Likewise, various different components may be includedwithin the non-disposable elements of the device 100. Such componentsmay be distributed among the disposable and non-disposable portionsbased on various relevant criteria (e.g., component cost, availabilityof components, cartridge footprint, device sensing capabilities, etc.).

FIG. 5 illustrates a side elevation view of an exemplary embodiment of acartridge 500 used by some embodiments (e.g., cartridge 240 describedabove). FIG. 6 illustrates a top plan view of the exemplary cartridge500. FIG. 7 illustrates a bottom plan view of the exemplary cartridge500. As shown, the cartridge may include a top plate 510, microfluidicchip 520, and a bottom plate 530.

The top plate 510 may be made of rigid or semi-rigid material (e.g.,plastic, metal, etc.). The top plate may include various clips orfasteners 540 or other elements that may secure the top plate 510 to thebottom plate 530 (thus securely housing the chip 520). Differentembodiments may couple the top plate 510 to the bottom plate 530 invarious appropriate ways using various appropriate elements (e.g.,screws, magnets, nuts and bolts, adhesives, tabs and slots, latches,etc.). Fasteners 540 may be distributed about the perimeter of the topplate 510.

The top plate 510 may also include a receptacle 610 with an opening 620for sample collection. The receptacle 610 and opening 620 may be sizedsuch that a typical user is able to put a fingertip in contact with theedges of the opening 620 such that a tight seal is formed between theskin and the receptacle 610. For instance, the opening 620 may be sizedto have a larger diameter than shown, as compared to the receptacle 610.In addition, other attributes of the receptacle 610 and/or opening 620may be varied (e.g., slope, contour, size, shape, material, texture,etc.) in order to generate necessary pressure for sample collection.

The top plate 510 may further include various through-holes 630 thatcorrespond to “pinch points” of the chip 520. Such pinch points mayprevent fluids from flowing within the chip until a test is conducted.In addition, after a test is completed, the pinch points may allow aused chip to be sealed such that fluids will not leak out. The pinchpoints may also be used when manufacturing cartridges. Cartridges mayinclude various cavities that may be pre-filled with various fluids(e.g., thinners, test solutions, antibodies, etc.). Such cavities may befilled by injecting a syringe into the cavity, depositing the fluid,retracting the syringe, and sealing the entry hole. By activating thepinch points, the fluid may be retained in the designated cavitiesduring manufacturing and storage prior to use.

In addition to the top plate 510, some embodiments may include a cover(not shown). Such a cover may be included over the top plate such thatelements of the test cartridge 500 are protected (e.g., the samplecollection point may be covered to prevent contamination). In addition,the cover may include various prongs that engage the pinch points of thechip 520 via through-holes 520. The cover may include various clips orconnectors that may secure the cover to the other elements of thecartridge 500. The clips or connectors may be automatically releasedwith the cartridge is placed in the SCTD 100 such that the cover may beremoved. When the test is complete, the cover may be reattached tosecure the cartridge 500 for disposal.

The chip 520 may be similar to chip 325 and chip 410 described above.The chip 520 may include various cavities, fluid conduits, opticalaccess points, and/or other appropriate elements. The chip may includecavities that are pre-filled with various solutions, materials, etc. Insome embodiments, the chip may include fluid sensing plates, connectors,etc. Such sensing elements may be contact and/or non-contact withrespect to the fluid under test. The chip may be made of flexiblematerial such as silicone.

The bottom plate 530 may be made of rigid or semi-rigid materials (e.g.,plastic, metal, etc.). The bottom plate may include a lancet housing 550and cap 560, which include a channel 570 for use by a lancet actuator ofsome embodiments. In addition, the bottom plate 530 may include varioustest leads or other connectors 580 that may be used to analyze samples,interface with various cartridge elements, etc. In some cases, the leadsmay extend into the chip 520 such that direct contact measurements maybe conducted.

The bottom plate 530 may include various placement guides 710 that mayalign the cartridge 500 with a complementary receptacle of the SCTD 100.In addition, the bottom plate 530 may include various cavities or accessareas 720 that may allow various elements of the SCTD 100 to engage thechip 520. For instance, some embodiments may include an access area 720for each pump that will engage the chip 520.

The bottom plate 530 may include a needle guide 730. The needle guidemay be an appropriately-sized through-hole that maintains needlealignments during sample generation.

FIG. 8 illustrates a side elevation view of the exemplary cartridge 500,including an exploded view of an exemplary lancet assembly 800. Asshown, the lancet assembly may include a spring 810, a needle or lancet820, a needle base or housing 830, a needle cup 840, and an actuatorinterface 850.

The spring 810 may include a linear spring and/or other components thatare able to retain the lancet assembly 800 at a starting position (andreturn the assembly to the starting position).

The needle 820 and base 830 may be standard lancet-type needlestypically used for blood sample collection. The length of the exposedportion of the needle 820 may be varied across different embodimentsdepending on various relevant factors (e.g., test type, user attributes,user preferences, etc.).

The needle cup 840 may be made from rigid material such as plastic ormetal. The needle cup may be sized and shaped such that it is able tomove along the housing 550 when manipulated by actuator interface 850.In addition, the interior cavity of the needle cup 840 may be sized andshaped to securely hold the lancet base 830 such that the needle 820 isextended along a consistently straight path.

The actuator interface 850 may be shaped and sized appropriate to movealong groove 570 such that lancet alignment is maintained through guide730. Different embodiments may include different actuator interfaces,depending on the type of lancet assembly, type of actuator, and/or otherrelevant factors. In this example, the bottom of the cup 840 may rest onthe actuator interface 850 as the cartridge 500 is inserted into theSCTD 100. The actuator interface 850 may be coupled to the actuator.

FIG. 9 illustrates a side elevation view of an exemplary embodiment of alancet actuator 900 included in the SCTD 100. FIG. 10 illustrates a sideelevation view of the lancet actuator 900 in an extended position. FIG.11 illustrates a top plan view of the top portion 910 of the lancetactuator 900. FIG. 12 illustrates a bottom plan view of the bottomportion 920 of the lancet actuator 900.

As shown, the actuator 900 may include a top portion 910 and a bottomportion 920 movable coupled along contour 930. In addition, someembodiments may include a center shaft or guide 940. The contour 930 ofthe coupling between the portions 910-920 may at least partially definevarious attributes of the lancet extension and retraction (e.g., depth,speed, acceleration, torque, duration, etc.). As such, differentembodiments may utilize differing contours 930 depending on variousrelevant factors (e.g., type of test, user attributes, user preferences,etc.). In addition, some embodiments may adjust various parametersassociated with the motor or driver for the actuator 900 (e.g., voltage,current, etc.).

The top portion 910 may be made from rigid materials such as metal orplastic. The top portion may include a through-hole or other receptacle1110 that is able to be movably coupled to guide 940 such that the topportion 910 is able to move back and forth (or up and down in thepictured orientation) along the guide 940. In addition, the top portion910 may include the actuator interface 850 and one or more additionalguides 1120 that may engage associated receptacles (not shown) of theSCTD 100 (or cartridge 500, and/or other appropriate elements). Suchalignment guides may help ensure that the lancet 820 is projected alonga consistent path and is thus consistently aligned relative to asubject.

The bottom portion 920 may be made of rigid materials such as metal orplastic. The bottom portion may include a through-hole or otherreceptacle 1210 that is able to be movably couple to guide 940 such thatthe bottom portion 920 is able to rotate about the guide 940. The bottomportion 920 may include a drive arm 1220 that is able to engage an armor other member coupled to a motor (e.g., a rotary motor, a linearactuator, etc.).

During operation, the bottom portion 920 may be rotated up to ninetydegrees, such that the actuator interface 950 is moved along the guide940 in an upward direction 1010 (or appropriate direction for theorientation of a particular lancet assembly and cartridge) toward theextended position shown in FIG. 10. The bottom portion 920 may then bereturned to the starting position (e.g., zero degrees of rotation), thusreturning the actuator interface 850 to the starting position shown inFIG. 9. Of course, the lancet assembly will also move along an axisaligned with guide 940 such that the lancet 820 is extended beyond thetop plate 510 in order to engage a subject and then return to a startingposition where the needle 820 is safely below the top plate 2510.

Some embodiments may utilize a two-step extension and retraction processwhere the bottom portion may be rotated such that the lancet 820 piercesthe microfluidic chip 520 and is located as close to the finger aspossible. The process may then extend and retract the lancet 820 toengage the subject and generate a sample. Such an approach may allow thechip to be pierced at a slow speed but the finger poking speed may berelatively higher.

FIG. 13 illustrates a schematic block diagram of a system 1300 includingthe automated SCTD 100, sample processing module 110, and a user device1310. As shown, the SCTD 100 may include a controller 1320, locationmodule 1330, position sensors 1340, UI module 1350, communication module1360, camera 1370 (and/or other appropriate sensors), cartridgeinterface 1380, and volume measurement module 1390.

The sample processing module 110 may be similar to that described abovein reference to FIG. 2, FIG. 3, and FIG. 4. The module 110 may include aremovable test cartridge. The cartridge, or portions thereof, may bedisposable (i.e., intended for a single use). several exemplary modules110 will be described in more detail in reference to FIG. 16-FIG. 18below.

The user device 1310 may be an electronic computing device, such as asmartphone, tablet, personal computer, medical device, etc. The userdevice may provide various system features, such as UI output elements(e.g., display of test results, status, etc.), UI input elements (e.g.,menus, buttons, etc.), and/or connectivity (e.g., via a cellular orwireless network connection). In some embodiments, the user device maybe able to at least partly control the operations of the SCTD 100. Forinstance, a user such as a medical professional may initiate a testsequence by pressing a button on a tablet after a subject has beenproperly positioned with respect to the SCTD 100 (and sample collectionelement thereof).

The controller 1320 may be an electronic device that is able to executeinstructions and/or process data. The controller may be able to at leastpartly direct the operations of the other components. The controller maybe associated with a local memory (not shown) that is able to storeinstructions and/or data.

The location module 1330 may include various electronic components thatare able to determine a geographic location. Such components mayinclude, for instance, global positioning system (GPS) components.

The position sensors 1340 may include various sensors, accelerometers,gyroscopes, etc. that may be able to determine a relative position ofthe SCTD. Such components may be used to ensure, for instance, that theSCTD is on a level surface. Some embodiments may include components thatare able to automatically adjust device position based on such sensormeasurements.

The UI module 1350 may include various buttons, touchscreens, displays,indicators, keypads, microphones, speakers, etc. that may allowinteraction with a user and/or subject.

The communication module 1360 may be able to communicate across one ormore wired or wireless pathways. Such pathways may include, forinstance, universal serial bus (USB), Bluetooth, Wi-Fi, Ethernet, theInternet, etc.

The camera 1370 (and/or other appropriate sensors) may be a color, HDcamera that is able to capture video and/or still photographs. Suchcaptured data may be able to be automatically analyzed by the controllerand/or other components. Other embodiments may include different typesof sensors such as environmental sensors (e.g., temperature, humidity,elevation, barometric pressure, etc.), subject attribute sensors (e.g.,temperature, pulse rate, blood pressure, etc.), etc. In someembodiments, the sensors may be provided by one or more externalcomponents, with a resource such as controller 1320, via communicationmodule 1360, may retrieve the data from such external components.

The cartridge interface 1380 may include various components appropriatefor interaction with a removable test sample processing module 110. Forinstance, some embodiments may utilize the camera 1370 to scan a graphiccode on the test cartridge. As another example, some embodiments mayinclude components that are able to read radio frequency identification(RFID) tags or other similar tags. As still another example, someembodiments may be able to retrieve information through a digital oranalog connection to the sample processing module 110. As yet anotherexample, some embodiments may utilize near-field communication (NFC).

In some embodiments, the cartridge interface 1380 and sample processingmodule 110 may have shared elements, complementary elements, and/orotherwise associated components that may together provide variousfunctions described in reference to the cartridge.

The volume measurement module 1390 may be able to interact with thecartridge interface 1380 (and/or other appropriate elements) in order todetermine volume measurements associated with sample fluids. Asdescribed in more detail in reference to FIG. 21 below, the volumemeasurement module 1390 may include and/or interact with various otherelements (e.g., optical sources and sensors) that are able to determinea volume of a fluid sample.

FIG. 14 illustrates a schematic block diagram of a cartridge interface1380 included in the automated sample collection and testing device 100.The interface 1380 may be able to access various components of the SCTD100 and/or the cartridge 240. As shown, the cartridge interface 1380 mayinclude a controller 1410, a controller interface 1420, a cartridgescanner 1430, a balloon controller 1440, an actuator driver 1450, anextraction controller 1460, a flow controller 1470, a detection module1480, and an analysis module 1490.

The controller 1410 may be an electronic device that is able to executeinstructions and/or process data. The controller may be able to at leastpartly direct the operations of the other components. The controller maybe associated with a local memory (not shown) that is able to storeinstructions and/or data.

The controller interface 1420 may interface with the controller 1320 ofthe SCTD 100. In some embodiments, controller 1320 may serve ascontroller 1410 and interface 1420.

The cartridge scanner 1430 may be able to scan a cartridge using radiofrequency scanning (for cartridges with RF tags, NFC tags, etc.),optical scanning (for cartridges with graphic codes), and/or otherappropriate components that may be used to determining identifyinginformation regarding a cartridge.

The balloon controller 1440 may control operations of a balloon (e.g.,balloon 310) and/or associated pumps or other components in order toensure sufficient retention of a subject appendage for samplecollection.

The actuator driver 1450 may control operations of an actuator (e.g.,actuator 335 or 900) in order to control lancet extension andretraction.

The extraction controller 1460 may be able to direct elements, such aspumps, that may be used to extract and collect a sample.

The flow controller 1470 may be able to direct elements, such as pumps,valves, etc., that may affect flow along various pathways of the chip520.

The detection module 1480 may measure information related to a testassociated with a cartridge. Such detection may include, for instance,charge detection, magnetic detection, impedance measurements, etc.

The analysis module 1490 may analyze detected measurements and/oridentify test results.

FIG. 15 illustrates a schematic block diagram of a cartridge 1500 usedby the automated SCTD 100. The cartridge 1500 may be similar tocartridge 240 or cartridge 500 described above. As shown, the cartridge1500 may include a communication module 1510 and one or more detectionelements 1520.

The communication module 1510 may provide NFC and/or other communicationcapabilities. The module may have an associated storage. Such elementsallow used cartridges to be “tagged” such that the cartridges areprevented from being used by multiple users or multiple times by thesame user.

The detection elements 1520 may include various contact and/ornon-contact elements that may provide measurement capabilities. Suchelements may include various leads or connectors that may interface withthe SCTD 100. In some embodiments, the detection elements 1520 maytransmit data via the communication module 1510.

FIG. 16 illustrates a schematic block diagram of an exemplary embodimentof the sample processing module 110. As shown, this example module mayinclude a sample collection element 1605, multiple optical measurementelements 1610-1615 (e.g., lasers, LED light sources, etc.), multiplebi-directional pumps 1620-1635, multiple cavities 1640-1655, anelectromagnet 1660, a pair of charge detectors 1665-1670, a differentialoutput generator 1675, a camera 1370, and a processor 1320. This examplesample processing module 110 is associated with tests to diagnosecancer. Different embodiments may include different components and/orarrangements of components when associated with other tests (e.g., bloodsugar levels).

The sample processing module 110, or portions thereof, may beself-contained such that each subject may use a new disposablecartridge. As such, the fluid collected by the cartridge may becompletely contained within the cartridge and not exposed to the SCTDdevice 100. The cartridge elements may be made out of (and/or enclosedor embedded in) appropriate materials that are impervious to the variousfluids collected or used within the sample processing module 110. Suchmaterials may include plastics, silicone, composites, etc. In thisexample, the fluid flow pathway is indicated by thicker arrows, whilecommunicatively coupled elements are indicated by thinner lines orarrows. In addition, the components that contact the sample areindicated by a fill pattern.

In some embodiments, the disposable cartridge portion may include thesample collection element 1605, the cavities 1640-1655, and the tubingbetween them. Such a configuration allows the more expensive components(such as pumps, optical detectors, etc.) to be reused across multiplecartridges.

The sample collection element 1605 may be similar to that describedabove in reference to FIG. 3 or FIG. 4. At minimum, the samplecollection element may include a cavity that is able to receive anamount of fluid for testing. In some embodiments, the cavity may includea fluid sensing chip. Some elements of the sample collection element(e.g., the pump or pinch valve) may be shared with other elements of thesample processing module 110. For instance, pump 1620 may act as pump315 in some embodiments.

Each of the pumps 1620-1635 may be a peristaltic or other appropriatepump that is able to move fluid along a flow pathway (e.g., the areasindicated by the fill and thick arrows). Such a pathway may includevarious flexible tubes or cavities within a fluid retaining housing(e.g., a silicone housing). In some embodiments, a peristaltic pump maymove fluid along the pathway. Such pumps may also act as valves, suchthat when the pumps are not operating, fluid flow between cavities(and/or other elements along the pathway) is prevented.

Each of the multiple optical measurement elements 1610-1615 (or otheroptical sensors, or other types of volume measurement sensors) mayinclude a source and a collector or absorber. The optical measurementelements may be placed along the fluid flow pathway such that fluid flowis able to be detected. The optical sensors 1610-1615 of someembodiments may be utilized without contacting the fluid sample. In thisway, the cost of cartridges may be reduced as the sensors are able to beused across numerous samples.

Each of the multiple cavities 1640-1655 may be able to store anappropriate amount of fluid. The cavities may be connected to the flowpathway at multiple locations (e.g., an input and an output).

The electromagnet 1660 may include various appropriate components thatare able to provide a controllable magnet.

The pair of detectors 1665-1670 (e.g., charge detectors, impedancedetectors, conductivity detectors, etc.) may include various elementssuch as metal plates, capacitors, circuitry, etc. that may be able todetect and/or store charge, and/or otherwise sense qualities of thecavity contents.

The differential output generator 1675 may be able to receive theoutputs of the charge detectors 1665-1670 and generate a signal 1680that is proportional to a difference in sensed charge at each chargedetector 1665-1670. The differential output 1680 may be provided as ananalog and/or digital signal. The output may be provided to a processor1320, as shown, and/or may be provided directly to an external resourcesuch as the SCTD 100.

The camera 1370 may be able to capture images and/or video associatedwith the sample processing module 110. The camera 1370 may be placedabove the sample processing module 110 such that activity inside thecartridge may be monitored. The camera 1370 may be able to track fluidmovement (and/or other appropriate factors) in real time such thatadjustments may be made or problems identified. In some embodiments, thecamera may be associated with the SCTD 100 rather than included in thedisposable cartridge in order to reduce cartridge cost. The camera 1370may be high definition, 4K, and/or other appropriate formats of anyresolution. Higher resolutions may provide more image processingcapability if needed.

The processor 1320 may be an electronic device capable of executinginstructions and/or processing data. The processor may be able to atleast partly control the operations of the various other components(although various connections have been omitted for clarity). Forinstance, the processor may direct the operations of the electromagnet1660. As another example, the processor 1320 may receive and analyzedata from the optical measurement elements 1610-1615. The processor 1320may have an associated memory (not shown).

Although this example includes charge detectors 1665-1670 and anelectromagnet 1660 that are used for charge differential detection,other embodiments may utilize other sensing components. For instance,some embodiments may include active electronic components such assensors that directly contact the fluid sample. In such cases, a signalfrom such a component may be received and analyzed by the processor 1320of some embodiments (and/or other appropriate components such as asensor interface). Some embodiments may utilize inductive power andwireless data exchange such that no physical connections to the chip areneeded.

FIG. 17 illustrates a schematic block diagram of a second exemplaryembodiment of the sample processing module 110. As shown, the module mayinclude many of the same components as the module of FIG. 16. In theexample of FIG. 17, the second cavity 1645 may be associated with achemiluminescence (CL) detector 1700. Such a detector may be able tosense photons emitted from CL particles. In addition, unlike the exampleof FIG. 16, the charge detectors 1665-1670 and second measurementelement 1615 are not needed. The output of the CL detector 1700 may beconverted to a discrete value and supplied to a processor (and/or otherappropriate elements), as in FIG. 16. Similar such processing elementsmay at least partly direct the operations of the components of thesample processing module 110.

As above, in this example, the fluid flow pathway is indicated bythicker arrows, while communication pathways among elements are omittedfor clarity. In addition, the components that contact the sample areindicated by a fill pattern.

FIG. 18 illustrates a schematic block diagram of a third exemplaryembodiment of the sample processing module 110. As shown, the module mayinclude a sample collection element 1810, multiple optical measurementelements 1820, multiple bi-directional pumps 1830, multiple emptycavities 1840, multiple pre-filled cavities 1850, multiple detectors1860, at least one electromagnet 1870, and a fluid output port 1880.

The sample collection element 1810 may be similar to element 1605described above. Each optical measurement element 1820 may be similar tomeasurement elements 1610-1615 described above. In this example,measurement elements 1820 are located throughout the module 110. Such anarrangement may be useful while developing or testing a new module orcartridge. Some embodiments may omit some such elements in order toreduce cost. Each bi-directional pump 1830 may be similar to pumps1620-1635 described above. The electromagnet 1870 may be similar toelectromagnet 1660 described above.

Each empty cavity 1840 may be similar to cavities 1640-1655 describedabove. Each pre-filled cavity 1850 may be similar to cavities 1640-1655described above and may include various solutions, materials, etc. thatmay be used during performance of the associated test. In this example,a first pre-filled cavity 1850 includes a buffer solution (BS), a secondpre-filled cavity includes antibodies (AB) that may be electricallycharged or tagged with particles that are attached to the AB molecules(e.g., gold particles of various sizes), and a third pre-filled cavityincludes certain agents or proteins attached to magnetic beads (MB). Thesize and/or other characteristics of each cavity 1840-1850 may depend onvarious relevant factors (e.g., desired volume, properties of storedsolutions or materials, etc.).

Each detector 1860 may be capable of detecting various attributes of thecontents of an associated chamber 1840 or 1850. Such attributes mayinclude, for instance, charge, impedance or conductance, pH level, coloror other visual attributes, and/or any other measurable attribute of thefluid.

The fluid output port 1880 may allow fluid to be provided to an externalelement via the cartridge of some embodiments. For instance, thecartridge may be removed and fluid collected from the cartridge forfurther analysis.

In this example, elements having a fill pattern are associated with adisposable portion of the module 110, while elements having no fillpattern are associated with the reusable portion of the module.

The outputs of the detectors 1860 may be converted to a discrete valueand supplied to a processor (and/or other appropriate elements), as inFIG. 16. Likewise, such elements may be able to at least partly directthe operations of the various pumps 1830, measurement elements 1820,sample collection element 1810, detectors 1860, electromagnet 1870, etc.

Several sample operations of the sample processing modules of FIG.16-FIG. 18 will be described in more detail in references to processes3900-4100 below. In these examples, the sample collection modules mayinclude similar (or the same) reusable components. For instance,although the different examples may include different numbers ofcavities within the disposable cartridge, each example uses the samenumber of pumps (where the layout of each different cartridge may bearranged to utilize those pumps). Different embodiments may utilizedifferent numbers of pumps (or other such reusable components) as well.In addition, the reusable components may include elements (e.g., the CLdetector 1700) that are only used by some embodiments of the disposablecartridge.

FIG. 19 illustrates a partial side view of a sample processing module110 including a disposable cartridge (or “insert”) 1910 according to anexemplary embodiment. This example includes a sub-set of the componentsdescribed above in reference to FIG. 16.

As shown, the sample processing module 110 of FIG. 19 may include theremovable insert 1910 including a fluid flow pathway 1920, a top portion230, and a bottom portion 220. In some embodiments, the top and bottom220-230 may be reusable and may include a solid housing made of, forexample, plastic or metal. The top and bottom may be coupled together(and/or to the device housing) in various appropriate ways, includinghinges, latches, tabs and sockets, nuts and bolts, compression fit,magnets, etc.

The removable insert 1910 may be made of (or housed within) a flexiblematerial such as silicone such that inserts may be inserted into and/orremoved from the cartridge housing. The insert may include variousridges, notches, slots, cavities, receptacles, etc. that may engagecomplementary elements of the cartridge housing.

FIG. 20 illustrates a partial top view of a disposable insert 1910 andsample processing module 110 according to an exemplary embodiment. Thisexample includes the same sub-set of components shown in FIG. 19. In theview of FIG. 20, the top portion 230 has been omitted for clarity.

As shown, the disposable insert 1910 may house at least a portion of thesample collection element 1605, cavity 1640, and cylindrical tubes orother appropriate connectors. The pump 1620 may engage a portion of theflow pathway 1920 without contacting the sample. For instance, the pump1620 may be a peristaltic pump that includes a rotating member with anumber of protruding ridges aligned with a portion of the insert tubing1920. The optical measurement element 1610 may be associated with atransparent or semitransparent portion of the insert 1910 and associatedtubing 1920. The optical measurement element 1910 may be orientedvertically, as in FIG. 19, horizontally, as in FIG. 20, and/or other mayutilize other appropriate orientations.

FIG. 21 illustrates a side elevation view of an optical measurementelement 1610 or 1615 according to an exemplary embodiment. As shown, theoptical measurement element may include an emitter 2110, an absorber2120, a beam 2130, a fluid path 2140, forward flow direction 2150, fluidsample 2160, starting edge (or “leading” edge) 2170, and ending edge (or“trailing” edge) 2180. The operation of the components of the opticalmeasurement element 1610 may be at least partly controlled by a resourcesuch as controller 1320.

At least some portions of the pathway 2140, including any portionsassociated with a beam 2130, may be translucent or semi-translucent suchthat more energy is able to be measured at the absorber 2120. When anopaque or semi-opaque fluid (such as blood) passes through that portionof the pathway 2140, the amount of energy measured at the absorber 2120may decrease versus the energy absorbed when there is a lack of fluid inthe pathway. An appropriate threshold may be set such that fluid flow atthe particular location may be detected. The optical sensors 1610 may beplaced before and/or after an associated pump (and/or other appropriatecomponents).

In this example, the emitter 2110 is on one side of the fluid path 2140while the absorber 2120 is on an opposite side. The path 2140 may beembedded into an insert, such as path 1920 in insert 1910. In someembodiments, the emitter 2110 and absorber 2120 may both be on one sideof the fluid path 2140 (e.g., both may be housed within the bottomportion 220 of the sample processing module 110), while a reflectiveelement is located on the opposite side. Such embodiments may reduce thecost of components included in the disposable cartridge 240. In someembodiments, the absorber(s) 2120 may be located within the top portion230 of the sample processing module. In other embodiments, theemitter(s) 2110 may be located within the top portion 230 of the sampleprocessing module while all other components are included within thebottom portion 220.

Some embodiments may include other types of optical sensors. Forinstance, some embodiments may utilize an LED light source and aphotodetector. The photodetector may have an analog output that is fedto an analog to digital converter for processing. Such a scheme may beused to measure volume by determining a length of fluid (e.g., severalmicrons), and calculating a volume based on a diameter of a tube orother connecting element. The output of the photodetector may beanalyzed by a processor to determine the beginning and end of a volumeof fluid. Such an approach may allow very accurate measurement ofvolumes.

Some embodiments may capture, store, and/or analyze a signal that isgenerated based on the output of the photodetector or other absorbingelement. Such an approach may allow the device to handle issues such asgaps in the fluid sample along the pathway. The signal may be stored(along with other test parameters) for future analysis.

In some embodiments, the detector 1610 may measure a volume of fluid byincrementing a counter while the detector 1610 senses an opaque fluid,where the count may be able to be translated to a fluid volume based onthe sizing of the tubing 2140 and count value. As each count incrementmay be associated with a very small amount of fluid, counting a largenumber of increments (e.g., five hundred, one thousand, etc.) mayprovide an accurate measure of volume.

In some embodiments, multiple detectors may be placed serially along apath in order to measure flow rate or viscosity. Of course, as in theexample of FIG. 18, such detectors may be utilized for other purposes aswell. Such flow rate detection may be used to measure performance ofblood thinners. For instance, a leading edge of a sample may be detectedat a first detector at a first time. The leading edge of the sample maybe detected at a second detector at a second time. The differencebetween the first time and the second time may be used to calculate a“thickness” or viscosity parameter that may be used to evaluate theperformance of the blood thinner.

FIG. 22 illustrates a schematic block diagram of an optical measurementelement 1610 according to an exemplary embodiment. As shown, the opticalmeasurement element may include an emitter 2110 and an absorber 2120.The emitter 2110 may include one or more optical sources 2210. Theabsorber 2120 may include a sensor 2220, digitizer 2230, filter 2240,camera 2250, and UI interface 2260.

Each optical source 2210 may include an optical output element such asan LED, bulb, laser, etc. The optical source(s) may be arranged in anarray in some embodiments. As described in more detail in reference toFIG. 23 below, the emitter 2110 may include various other elementsassociated with the source 2210. The beam (or “light pipe”) 2130 formedby the source(s) 2210 may be adjustable or configurable in various ways(e.g., power to the source may be varied, different numbers of sourcesmay be activated, etc.).

The sensor 2220 may include various components that are able to sensethe beam 2130. Such an output may represent a relative amount of sensedlight expressed from a minimum value to a maximum value. Performance ofthe sensor 2220 may be configurable in various ways. For instance, someembodiments may allow parameters such as light sensitivity, gain, outputrange, input range, etc. to be modified depending on various appropriatecriteria (e.g., test type, sample properties, practitioner or patientpreferences, etc.).

The digitizer 2230 may receive the output signal generated by sensors2220 and convert any analog outputs into digital signals. The digitizer2230 and sensor 2220 may be combined into a single sensor element thatgenerates a digital output signal. In some embodiments, for example, thesensor 2220 may produce an output between zero volts (no light sensed)to five volts (maximum light sensed, i.e., fluid path is clear). Such anoutput may be digitized to reflect values between zero and one thousandtwenty-four (or other appropriate values, depending on available numberof bits and capabilities of the sensing devices). The output of thedigitizer 2230 may be used to determine a color density, depth, orsaturation.

The filter 2240 may perform various processing operations on the digitaloutput signal received from the digitizer 2230 or sensor 2220. Suchprocessing may include, for instance, averaging or other smoothing, gainor other normalizing adjustments, color filtering or other signalprocessing, etc. The filtered output may be provided to a resource suchas controller 1320.

The camera 2250 may be able to capture images or video associated with aportion of the fluid path 1920 that is illuminated by beam 2130 (and/oranother appropriate resource). The UI interface 2260 may receivecaptured data from the camera 2250 and provide the data to a resourcesuch as UI module 1350. The camera 2250 and UI interface 2260 may allowa patient or practitioner to monitor sample flow during a test.

FIG. 23 illustrates a schematic block diagram of various opticalprocessing components associated with an optical measurement element1610 in some embodiments. As shown, the optical measurement element mayinclude a source 2210, a first optical filter 2310, and a second opticalfilter 2320.

In some embodiments, the source 2210 may radiate light over a range ofoutput directions 2330. Filter 2310 may focus the beams 2330 into asingle more powerful beam 2130 and/or otherwise manipulate the beams2330 (e.g., by modifying the color of the beams). In some embodiments,the filter 2310 may be integrated into the housing of source 2210 or maybe omitted. Some embodiments, as described below, may focus or filterthe beam through an appropriately-sized opening in a portion of thecartridge 1910.

The filter 2320 may be similar to filter 2310. Some embodiments may omitone or bother filters 2310-2320. The output beam 2340 produced by filter2310 may be provided to sensor 2220.

Different combinations of filters and/or other elements may be utilizedto maximize contrast. For instance, when measuring red blood, someembodiments will utilize a light source 2210 and/or filter 2310 thatproduce a blue beam 2130. Continuing the blood example, filter 2320 maybe a blue filter and the sensor 2220 may be specifically configuredand/or selected to have peak sensitivity to light at the bluewavelength. Thus a clear fluid path 1920 would produce a very clear bluelight pipe 2130 with maximum contrast versus a blood-filled portion ofthe fluid path 1920.

FIG. 24 illustrates a top plan view of a portion of a cartridge 1910associated with an optical measurement element 1610 in some embodiments.FIG. 25 illustrates a side elevation view of a portion of a cartridge1910 associated with an optical measurement element 1610 in someembodiments.

As shown, an area associated with optical element 1610 may includeopaque or light-absorbing material 2410 (e.g., dark paint or othersurface coating, embedded plastics, metals and/or other opaque elements,etc.). The light absorbing material may be applied to various surfacesof a cartridge 1910 (and/or other appropriate elements). In someembodiments, the material 2410 may be embedded into portions of thecartridge 1910.

Such material may reduce interference among multiple optical elements1610 and/or other sources of light. The cartridge 1910 may include anopening (or “optical pathway”) 2420 that is used to generate the lightpipe 2130. In some embodiments, the opening 2420 may have a diameter ofthree millimeters. The size of the opening may be based at least partlyon the size of the fluid pathway 1920 (e.g., the opening, and thus thelight pipe, may be sized to have a slightly smaller diameter than thepathway). The opening may simply be an area with no opaque material2410. In some embodiments, the opening 2420 may include a cavity orthrough-hole with opaque material 2410 lining the interior wall orsurface of the cylinder 2420 along the portions that do not intersectthe pathway 1920.

Some embodiments may include one or more light guides 2430. Such lightguides may be located in a top plate 2440 and/or bottom plate 2450 ofsome embodiments. The top plate 2440 and bottom plate 2450 may beadjacent to the cartridge 1910 during operation. The source 2110 andabsorber 2120 may be attached to PC boards that sit on the oppositesides of the plates 2440-2450 from cartridge 1910. Some embodiments mayinclude a surround (e.g., a black plastic tube) that encloses either orboth light guides 2430. Some embodiments may include one or moresurrounds and omit one or more of the light guides. The light guides2430, surrounds (not shown), light absorbing material 2410, and/or otherelements may together form the “light pipe” 2130 of some embodiments.

One of ordinary skill in the art will recognize that the examplearchitectures described above are exemplary in nature and differentembodiments may be implemented in different specific ways withoutdeparting from the scope of the disclosure. For instance, variouscomponents may be combined or separated. As another example, variouscomponents may be distributed differently than shown (e.g., one or morepumps may be included in a disposable cartridge in some embodiments). Asstill another example, different embodiments may include differentnumbers of pumps, optical measurement elements, cavities, etc.Furthermore, different embodiments may be sized or shaped differentlydepending on the application. Such differences may include differentlayouts of internal components, circuitry, etc.

II. Methods of Operation

FIG. 26 illustrates a flow chart of an exemplary process 2600 thatcollects and tests a sample using the automated SCTD 100. The processmay begin when the device is powered on, when a sample processing module110 is inserted, and/or other appropriate times.

As shown, the process may determine (at 2610) whether a cartridge ispresent. If the process determines that no cartridge is present, theprocess may end. If the process determines that a cartridge is present,the process may identify (at 2620) the cartridge. Such identificationmay include scanning of a graphic code, reading an RFID, receiving userinput from an external device, etc.

Next, the process may retrieve (at 2630) cartridge attributes. Suchattributes may be retrieved from the cartridge itself, from a local orremote database or look-up table, from user inputs, etc. The cartridgeattributes may include, for instance, test type, fluid amounts (e.g.,minimum sample volume), durations of operations (e.g., pulse countsassociated with fluid measurements, reaction times, etc.), test orevaluation thresholds, etc.

The process may then determine (at 2640) whether the sample collectionhas been activated. Such a determination may be made based on variousrelevant factors, such as whether a finger (or other appropriate samplecollection point) has been detected. Such a determination may be madeusing, for instance, the camera of some embodiments, a user input, apressure sensor, etc.

If the process determines that no finger is detected, the process maycontinue trying to detect a finger until the process determines that afinger is detected. If the process determines that a finger is detected,the process may collect (at 2650) a sample. Such a sample may becollected using a needle and/or other appropriate elements as describedabove. Sample collection will be described in more detail in referenceto process 2700 below.

Next, process 2600 may process (at 2660) the sample. Several example ofsuch processing is described in more detail in reference to processes3900-4100 below.

The process 2600 may then collect (at 2670) test attributes. Suchattributes may include, for instance, charge difference at a pair ofcharge detectors, impedance or conductance of a sample (and/or processedsample), pH level, and/or any other measurable attribute of the fluid.

Next, the process may provide (at 2680) the results, and then may end.Such results may be based on comparison of the test attributes to one ormore threshold values. The results may include discrete values (e.g.,“pass”, “fail”, “inconclusive”, etc.), measured values (e.g., weight orpercentage of some tested parameter), and/or other appropriate resultformats. The results may be provided via the SCTD 100 (e.g., using UI120), a user device or medical device 1310, and/or other appropriateways. Some embodiments may send the results (and/or measure orintermediate values) to multiple external devices or systems using anelement such as communication module 1360.

FIG. 27 illustrates a flow chart of an exemplary process 2700 thatcollects a sample using the automated SCTD 100. The process may beginwhen sample collection is activated as described in reference tooperation 2640 above.

As shown, the process 2700 may open (at 2710) a valve such as pinchvalve 320. Next, the process may activate (at 2720) a sample mechanism.Such a mechanism may include elements such as needle and spring 345,receptacle 340, and chip 325 described above. Activation of the samplingmechanism will be described in more detail in reference to process 2800below.

Next, process 2700 may activate (at 2730) a collection pump, such aspump 315. The process may then monitor (at 2740) a measurement elementsuch as element 1610 described above. Alternatively, some embodimentsmay monitor collection using a camera, scale, etc. Some embodiments maysimply utilize a timer rather than attributes associated with the sampleitself.

The process may then determine (at 2750) whether the collected quantityis sufficient for the associated test. Such a determination may be madebased on various relevant factors (e.g., counter value, weight ofsample, etc.).

If the process determines the quantity is not sufficient, the processmay then determine (at 2760) whether a sample timeout has been exceeded.If the process determines (at 2760) that the sample timeout has not beenexceeded, the process may repeat operations 2740-2760 until the processdetermines (at 2750) that the quantity is sufficient or the processdetermines (at 2760) that the timeout has been exceeded.

If the process determines (at 2750) that the quantity is sufficient, orif the process determines (at 2760) that the sample timeout has beenexceeded, the process may deactivate (at 2770) the collection pump,close (at 2780) the valve, generate (at 2790) a completion signal, andthen end. The completion signal may be an internal signal that isrelayed to an element such as controller 1320 and may be used as atrigger to continue operations of process 2600 after collecting a sampleat 2650. In some cases, no further processing may be performed aftersample collection, and the completion signal may include indications atUI 120, via user device 1310, and/or other appropriate signals.

The automated sample collection process (drawing the sample, performinga test, measuring the results) may be completed in two minutes or lessin most cases, thus allowing large-scale trials to be completed withless time spent collecting and testing samples and also reducing theamount of staff support needed to implement the trials.

In cases where the process determines (at 2760) that the timeout hasbeen exceeded, the completion signal may indicate that the samplequantity is insufficient. Such a signal may cause the process to bere-run, or may provide a UI indication that the sample is insufficientand instruct the subject to insert another finger (or take otherappropriate actions to successfully complete a sample collection, suchas the insertion of a new cartridge).

FIG. 28 illustrates a flow chart of an exemplary process 2800 thatcontrols a sampling element of the automated SCTD 100. The process maybegin when sample collection is activated as described in reference tooperation 2720 above.

As shown, process 2800 may retrieve (at 2810) sample collectionparameters. Such parameters may include, for instance, balloon pressure,needle extension, etc.

Next, the process may activate (at 2810) a pump such as rubber pump 305and monitor (at 2830) pressure at a retaining element such as balloon310. Next, the process may determine (at 2840) whether the specifiedpressure (or other parameter) has been reached. The process may repeatoperations 2830-2840 until the process determines (at 2840) that thespecified pressure has been reached.

Next, the process may extend (at 2850) an actuator such as actuator 335,such that the needle 345 or other sampling element is extended. Theactuator may be extended to a specified value or may be full extendedand limited by physical features of the needle, actuator housing, stops,etc.

The process may then retract (at 2860) the actuator and determine (at2870) whether the sampling is complete. Such a determination may be madein various appropriate ways. For instance, some embodiments may wait fora completion message as described above in reference to operation 2790.As another example, some embodiments may wait for a specified amount oftime. As still another example, some embodiments may wait for a userinput to be received via a UI element, user device, medical device, etc.

Some embodiments may extend the actuator using a two-step process tomaximize comfort and efficiency. The process may first move the needlesuch that a microfluidic chip of some embodiments is pierced and theneedle is “ready for sample”. Next, the process may extend and retractthe needle in order to generate the sample. Such an approach mayoptimize speed of movement of the lancet.

If the process determines (at 2870) that the sample is complete, theprocess may deactivate (at 2880) the rubber pump (and/or other retainingelements) and then may end.

FIG. 29 illustrates a flow chart of another exemplary process 2900 thatcontrols a sampling element of the automated SCTD 100. The process maybegin when calibrating an SCTD for a particular test type and/or toengage additional suction power when collecting a sample. Process 2900may be performed in serial or parallel with processes 2700 and/or 2800.

As shown, the process may determine (at 2910) whether an SCTD 100 hasbeen calibrated. Such a determination may be made based on storedparameters, hardware settings, etc. If the process determines that theSCTD has not been calibrated, the process may then perform (at 2920)calibration.

Calibration may involve successively performing a lancet extension andretraction until a sample is generated. Feedback may be provided by auser, or the process may automatically determine when a sample isextracted (e.g., by monitoring an optical element of some embodiments inorder to detect fluid flow), thus identifying an optimum sample depth.Alternatively, some embodiments may allow a user to specify a desireddepth (or utilize a default depth). Calibration may be performed using acalibration cartridge. Such a cartridge may omit various includedfeatures, materials, etc. in order to reduce cost and waste. Someembodiments may be able to calibrate depth to a resolution of onehundred microns.

After determining (at 2910) that calibration has already been performed,or after performing (at 2920) calibration, the process may apply (at2930) calibration parameters. Such parameters may include, for instance,depth, speed, duration, force, etc. Some embodiments may utilize defaultparameters when no user-specific and/or test-specific calibrationparameters are available.

Next, during sample collection, the process may determine (at 2940)whether sufficient extraction pressure has been reached. Such adetermination may be made based on various relevant criteria (e.g.,sample pressure may be measured directly, fluid pathways may bemonitored to determine if fluid is flowing from a collection point,etc.). If the process determines that there is not sufficient extractionpressure, the process may activate (at 2950) additional extractionpump(s).

For instance, in the example cartridge 110 of FIG. 18, multiple pumps1830 may be activated in order to draw fluid from collection point 1810.As another example, flexible microfluidic chips such as chip 520included in cartridge 500 may include an exhaust port (e.g., similar toport 1880) such that air (and/or other fluids) may be expelled when asample fluid is collected. Such an exhaust port may be coupled to a pumpthat may be activated to supply additional extraction pressure. Someembodiments may couple a pump such as balloon pump 315 to the exhaustport.

After determining (at 2940) that the sample pressure has been reached orafter activating (at 2950) the extraction pump(s), the process may end.

FIG. 30 illustrates a flow chart of an exemplary process 3000 thatimpels a small amount of fluid within the exemplary embodiments of thesample processing module 110. Such a process may be executed by the SCTD100 using an optical element such as element 1610. The process maybegin, for instance, when a sample is available or when a sample isbeing taken.

As shown, the process may retrieve (at 3010) a necessary (or minimum)sample volume. Such a volume may be retrieved from the cartridge, from adatabase or look-up table, received from a user, and/or otherappropriate resource. The volume may be expressed as a count value orother discrete value associated with different measurement algorithms ofdifferent embodiments.

Next, the process may activate (at 3020) the appropriate pump associatedwith the measurement. Such a pump may be similar to pumps 315 or1620-1635.

The process may then determine (at 3030) whether fluid is detected atthe location of the flow pathway associated with the optical sensor 1610(and/or other appropriate elements). Such detection may be based ondetection of a leading edge 2170 such as that described above. Theprocess may iteratively or continuously attempt to detect fluid untilthe process determines that fluid has been detected, at which point, theprocess may activate (at 3040) a counter or other timing algorithm.

Such a counter may be a digital and/or analog timer. In someembodiments, the counter may specify a duration during which the fluidis detected. In other embodiments, the counter may specify a number ofpump motor pulses to be applied (or a duration during which pulses areapplied). The counter may be incremented at regular intervals (e.g.,each clock period) when used to measure duration of time.

In some embodiments, as described above, the sensor 1610 output may beconverted to a digital or analog signal. In such cases, the signal maybe analyzed in various appropriate ways in order to generate a “count”value (where such a value, in addition to being a literal counter ortimer, may include any appropriate signal analysis). For instance, someembodiments may integrate the signal to calculate an area under a curvethat may be used as the count value in order to determine a volume. Asanother example, the signal may be associated with various thresholdsthat may be used to activate or deactivate the counter (e.g., thecounter value may increase when the signal is above a threshold and beheld constant when the signal is below the threshold).

Next, the process may determine (at 3050) whether the sample is complete(i.e., whether the specified volume has been collected). Such adetermination may be made based on whether a specified count thresholdhas been met or exceeded (and/or other appropriate analysis such ascomparison of area to a threshold value).

If the process determines (at 3050) that the sample is not complete, theprocess may repeat operations 3040-3050 until the process determines (at3050) that the sample is complete. In addition, the process may continueto monitor whether fluid is detected and may determine (at 3050) thatthe sample is complete when no more fluid is detected at the monitoredportion of the fluid pathway. Such a determination may be made based ona gap in fluid detection having a minimum width or time duration, asensor signal that drops below a specified threshold, etc.

If the process determines (at 3050) that the threshold volume has beencollected, the process may stop (at 3060) the counter, deactivate (at3070) the pump, send (at 3080) a completion message to other componentsor devices, and then may end.

FIG. 31 illustrates a flow chart of an exemplary process that measuresfluid parameters within the exemplary embodiments of the sampleprocessing module included in the sample collection and testing device110. Such a process may be executed by the SCTD 100 using an opticalelement such as element 1610. The process may begin, for instance, whenthe SCTD 100 is powered on.

As shown, process 3100 may activate (at 3110) an optical element of someembodiments (e.g., element 1610). In addition, some embodiments mayperform various calibration operations. Such operations could include,for instance, measuring absorber output with the emitter disabled,measuring absorber output with the emitter at maximum power and nocartridge inserted. As another example, some cartridges may include testfluids that may be used for calibration (e.g., a clear fluid and a redfluid) such fluids may be used only for calibration or may be associatedwith various substances used by the particular test cartridge (e.g., ablood thinner may be clear while an active agent may be dyed red).

Next, the process may determine (at 3120) whether the UI is enabled.Such a determination may be made based on various relevant factors(e.g., default parameters, test-specific parameters, user selections,etc.). If the UI is enabled, the process may capture data (e.g., usingcamera 1250) and provide (at 3130) the captured data to a UI module(e.g., by passing data from UI interface 1260 to UI module 1350). Photoor video data may then be displayed by the UI 120 of some embodiments.

After determining (at 3120) that the UI is not enabled, or afterproviding (at 3130) data to the UI module, process 3100 may capture (at3140) sensor data using a resource such as sensor 1220. Such data may bedigitized using an element such as digitizer 1230.

Next, the process may filter (at 3150) the captured data. Such filteringmay include, for instance, averaging or other smoothing, gain or othernormalizing adjustments, color filtering or other signal processing,etc. The filtering may be performed by a resource such as filter 1240.

Process 3100 may then provide (at 3160) the filtered captured data to aprocessor or other appropriate resource (e.g., controller 1320).

Finally, the process may store (at 3170) the captured data and then mayend. Such data may be stored locally and/or transmitted to various otherresources (e.g., user devices, servers, etc.).

In some embodiments, process 3100 may utilize feedback in order tooptimize performance during a measurement operation. Such feedback mayinclude, for instance, inputs received via UI 120 (e.g., a user maymanually adjust gain or sensitivity). In some embodiments, the feedbackmay be generated automatically based on received data (e.g., if allmeasured values have fallen within a limited range, gain or sensitivitymay be increased).

Some embodiments provide a test cartridge that includes an adjustablelancet (or needle). The adjustable lancet is controlled by a controller.The adjustable lancet automatically detects a subject's finger, adjuststhe lancet's height, pricks the finger to draw blood, moves a tube tocollect the blood, moves the tube away from the finger, and empties theblood from the tube into a vial or receptacle.

The adjustable lancet may include safety features to prevent the lancetto trigger when the subject's fingernail is facing the lancet, tocontrol the amount that the lancet pierces the subject's finger, and/orto prevent the reuse of a test cartridge for multiple persons ormultiple times by the same person. The adjustable lancet may include amassager wheel and/or a pressure bar to rub the subject's finger afterthe finger is pierced to facilitate drawing of the blood from thefinger.

FIG. 32 illustrates a perspective view of an exemplary embodiment of anadjustable lancet assembly 3200 used by the sample collection andtesting device of FIG. 1. FIG. 33 illustrates a perspective view of theexemplary adjustable lancet assembly 3200 of FIG. 32 with the massager3213 and the plate 3240 holding the massager 3213 removed. FIG. 34illustrates a side elevation view of the exemplary adjustable lancetassembly 3200 of FIG. 32. FIG. 35 illustrates a side elevation view ofthe exemplary adjustable lancet assembly 3200 of FIG. 32 with themassager wheel 3213 and the plate 3217 holding the massager wheel 3213removed.

As shown in FIGS. 32-35, the adjustable lancet assembly 3200 may includea finger receptacle 3201, a lancet housing 3202, a servo motor 3225 formoving the lancet housing 3202, a trigger handle 3204 for releasing thelancet, a servo motor 3203 for releasing the trigger handle 3204, amovable plate 3205 connected to the lancet housing 3202 and the servomotor 3203, a force (or pressure) sensor 3206, a tube 3207 to pick upblood, a movable plate 3208 connected to the tube 3207, a servo motor3209 that controls the movement of the plate 3208, a pump (not shown)connected to the end of the tube 3207, a pressure bar 3211, a servomotor 3212 the controls the movement of the pressure bar 3211, a fingermassager wheel 3213, a servo motor (not shown) to move the tube 3207forward and backward, one or more sensors and one or more light sources(shown in FIG. 36) to detect the fingernail, a handle 3216 connected tothe pressure bar 3211, a lancet housing cap 3217, a plate 3240 connectedto the massager wheel 3213, a servo motor 3225 to move the plate 3205 upand down, a servo motor 3230 to swing the massager wheel 3213, and aprotrusion 3240.

Operation of the adjustable lancet may be controlled by a controller.The controller may be an electronic device that is able to executeinstructions and/or process data. The controller may include a processorand may be able to at least partly direct the operations of the othercomponents. The controller may be associated with a local memory (notshown) that is able to store instructions and/or data. The controllermay be the same as the controller 1320 (FIG. 13) or the cartridgecontroller 1410 (FIG. 14) or may be a separate electronic device (notshown).

The finger receptacle 3201 is sized and shaped appropriately for a humanfinger. During operation, the finger is placed with the fingertip facingup towards the lancet housing 3202 and the fingernail facing down (inthe pictured orientation). Some embodiments provide a safety mechanismthat detects which side of the finger is facing the lancet. If it is thenail side is facing the lancet, the adjustable lancet's controller maygenerate an warning signal and may stop the operation of the adjustablelancet to prevent the possibility of the subject's fingernail beingpierced by the lancet.

FIG. 36 illustrates a front elevation view of an exemplary embodiment ofthe finger receptacle 3201 and the lancet housing 3202 of FIGS. 32-35.The finger receptacle 3201 may have different shapes to accommodatedifferent design goals. For example, the side 3670 may be longer thanthe side 3675 (as shown in FIGS. 32-35) to provide control the movementsof the massager 3213, as described below.

The finger receptacle 3201 may include different mechanisms to ensurethe subject's finger 3690 is placed on the finger receptacle 3201 withthe fingertip facing the lancet. For example, in some embodiments, theside 3680 that touches the finger may be made of a transparent materialsuch as, for example and without limitations, glass, clear plastic, etc.These embodiments may include one or more light sensors 3630 (e.g.,photodetector(s)) and one or more light sources 3635 (e.g., LED lightsource(s), laser(s), bulb, and/or other optical components).

The light source(s) 3635 may direct light to the finger through thetransparent side 3650 of the finger receptacle 3201. The light reflectedfrom the finger is then sensed by the light sensor(s) 3630. The lightthat is reflected from a fingernail is different than the lightreflected from the finger's skin. The sensed light may then be analyzed(e.g., by the adjustable lancet's controller) to determine whether thefingernail is facing down (opposite the lancet). Otherwise, thecontroller may generate a warning signal and stop the operation of theadjustable lancet.

The light sensor(s) and the light source(s) in different embodiments maybe placed in different locations. For example, in addition to, or inlieu of the light sensor(s) 3630 and the light source(s) 3635, someembodiments may include the light sensor(s) 3640 and the light source(s)3645 that are located on the lancet housing 3202 (e.g., on the lancethousing's body or lancet housing's cap 3217).

With reference to FIGS. 32-35, the adjustable lancet 3200 may include aforce (or pressure) sensor 3206. The force sensor 3206, for example andwithout limitations, may be a force-sensing resistor that includes amaterial whose resistance changes when a force, pressure, or mechanicalstress is applied to it. The force sensor 3206 may be communicativelycoupled to the adjustable lancet's controller. Based on the changes inthe value of the force sensor's resistance, the controller may determinewhether a finger is placed on the finger receptacle 3201 (e.g., toactivate the light source(s) 3635 and/or 3640).

The force sensor 3206 may also be used to determine whether the lancethousing 3202 (e.g., the protrusion 3240) has touched the finger. Thelancet assembly located inside the lancet housing 3202 may include aspring 3680, a cap 3685, a channel (or groove) 3689, a guide 3687, and alancet or needle 820. The lancet may be similar to the lancet 820 ofFIG. 8. The lancet assembly may also include the trigger handle 3204, acap 3217, and a protrusion 3240. The protrusion 3240 may be made of amaterial such as plastic, rubber, smooth metal and may slightly (e.g.,and without limitations, 1-5 millimeters) project out of the cap 3217.The protrusion 3240 may include a hole (not shown) on its center toallow the lancet 820 to come out. The cup 3685 may be shaped and sizedappropriately to move along channel 3689 such that lancet alignment ismaintained through guide 3687.

During operation, the adjustable lancet's controller slowly moves theplate 3205 (FIGS. 32-35) down by controlling the corresponding servomotor 3225 (FIGS. 34-35). The lancet housing 3202 and the servo motor3203 are connected to the plate 3205 and also move down. The force (orpressure) is continuously monitored by the force sensor 3206.

FIG. 37 illustrates a front elevation view of the exemplary embodimentof the finger receptacle 3201 and the lancet housing 3202 of FIG. 36when the lancet housing 3202 is lowered such that the protrusion 3240has touched the subject's finger 3690. Once the protrusion 3240 touchesthe finger 3690, the force (or pressure) reaches a predefined threshold,the controller stops the plate 3205. The controller may then move theplate 3205 back up by a small amount to relieve the protrusion'spressure from the subject's finger 3690. The amount the plate 3205 ismoved up may be programmable in some embodiments.

The controller may then release the lancet 820. The lancet 820 may moveout of the opening on the protrusion 3240 and prick the finger 3690. Thelancet 820 is then automatically removed from the finger eitherautomatically by a spring (not shown) or the controller may move theplate 3205 up and thereby move the lancet 820 and the lancet housing3202 away from the finger.

The lancet 820 may be released by controlling the servo motor 3203 torelease the trigger handle 3204. The spring 3680 may sit in the cup 3685and may apply pressure to the cup 3685. The trigger handle 3204 (asshown in FIG. 36) may sit in a slot 3740 (more clearly shown in FIG. 37)in the lancet housing 3202 and may prevent the cup 3685 to move down.

The controller may control the servo motor 3203 to move a handle (notshown) to move the trigger handle 3204 out of the slot 3740 (as shown inFIG. 37, in this example the trigger handle 3204 has rotated byapproximately 90 degrees). Once the trigger handle is moved out of way,the spring 3680 may push the cup 3685 and the lancet 820 towards thefinger 3690. With reference to FIG. 37, once the cup 3684 touches thecap 3217, the cap 3217 prevents the cup 3684 and the lancet 820 to moveany further, thereby preventing the lancet 820 to penetrate the finger3690 more than a predetermined amount.

With reference to FIGS. 32-35, once the finger is pricked, a certainamount of blood may come out of the fingertip. In order to facilitatedrawing blood, the adjustable lancet 3200 may include a massager wheel3213 and/or a pressure bar 3211. The massager wheel 3213 is shown inFIGS. 32 and 34 and is removed from FIGS. 33 and 35 in order to show thecomponents that are behind the massager wheel 3213.

The massager wheel 3213 may be covered by a flexible material such asrubber, silicone, foam, plastic, etc., and may massages the fingertip inorder to draw additional blood. The massager wheel 3213 may be connectedto a shaft (not shown). The controller of the adjustable lancet 3200 maycontrol the shaft by the servo motor (3230) to move the massager wheel3213 like a pendulum (e.g., in a left to right direction in the picturedorientation).

The shaft keeps the massager wheel 3213 at a position where the massagerwheel 3213 near the area that is pricked by the lancet. The location andthe pendulum movement of the shaft is configured such that the massagerwheel 3213 may touch the fingertip at a location close to where thefinger is pricked. The flexible material on the massager wheel 3213 maydeforms when it touches the finger in order to accommodate fingerdiameter of different persons.

With further reference to FIGS. 32-35, the pressure bar 3211 may beconnected to a shaft 3216 and the shaft 3216 may be connected to theplate 3250. The plate 3250 and the shaft 3216 may be moved towards andaway from the finger (e.g., in a left and right directions in thepictured orientation) by the servo motor 3212, which may be controlledby the adjustable lancet's controller. The pressure bar 3211 may be madeof (or be covered by) a flexible material such as rubber, silicone,foam, plastic, etc., and may apply pressure to the side of the finger inorder to draw additional blood. The operations of the massager wheel3213 and/or the pressure bar 3211 may simulate massaging the finger of asubject by a person.

Once the massager wheel 3213 and the pressure bar 3211 are stopped, thetube 3207 may be moved to come in touch with the blood to collect theblood. The tube 3207 may be a capillary tube (e.g., and withoutlimitation, a tube with a diameter of 0.5 millimeter to 3 millimeter)with an open end to touch the blood come out of the fingertip. The otherend of the tube 3207 may be connected to a larger tube (not shown) madeof silicone or other appropriate material. The larger tube may beconnected to a pump (not shown) to facilitate drawing the blood in thetube 3207. The pump may be a bi-directional peristaltic pump similar tothe pumps 1620-1635 of FIGS. 16-17 or the pumps 1830 of FIG. 18.

The tube 3207 may be made, for example and without limitations, ofplastic, metal (e.g., steel), or other appropriate material. The tube3207 may be connected to the plate 3208. The servo motor 3209 may beconnected to the plate 3208 and may be controlled by the adjustablelancet's controller to move the tube up and down and side to side in thepictured orientation.

The controller may control the servo motor 3209 to move the tube 3207down and another servo motor (not shown) to move the tube left (in thepictured orientation) towards the fingertip. At the same time, thecontroller may turn on the pump to run for a specified period of time topick up the blood from the fingertip. The tube is moved to a positionthat is in line with the needle and where it pricks the finger. Forexample, the vertical plate where the lancet 820 (FIG. 37) may move andthe distance 3670 that the lancet 820 may go down may be programmed intothe controller and the controller may use this information to move thetube such that the open end of the tube 3207 comes in touch with theblood drawn out of the finger.

The pump may then be stopped and the tube may be moved back by thecontroller using the servo motor 3209 and the plate 3208. The open endof the tube 3207 may be moved into a vial or a receptacle (not shown)and the pump may be turned on in the reverse direction for a specifiedperiod of time to push the blood that is in the tube 3207 into the vialor receptacle. In some embodiments, the blood may be directly depositedin a microfluid system for example and without limitations, through asample connection element 1605 (FIG. 16) instead of a vial orreceptacle.

Using the massager wheel 3213 and/or the pressure bar 3211, moving ofthe tube, collecting of blood by the tube, reversing of the pump, andremoving of the blood from the tube may be repeated several times tocollect a certain amount of blood. In some embodiments, the pump may notbe reversed and the desired amount of blood may be collected through thetube 3207 in a continuous operation.

The lancet housing 3202 and the components inside the lancet housing3202 (e.g., the lancet 830, etc.), the tube 3207, the pressure bar 3211,the massager wheel 3213 may be disposable and may be included in adisposable cartridge. The housing of the cartridge is not shown in FIGS.32-35 for simplicity. The location and sizes of different components ofthe adjustable lancet assembly may be different that the location andsize of the components of FIGS. 32-35 in order to fit the disposablecomponents in a disposable cartridge and/or to minimize the overall sizeof the adjustable lancet assembly and the SCTD.

The adjustable lancet 3200 may include a communication module such asthe communication module 1510 of FIG. 15 that may provide NFC and/orother communication capabilities. The module may have an associatedstorage. Such elements may allow used cartridges to be “tagged” suchthat the cartridges are prevented from being used by multiple users ormultiple times by the same user. The massager wheel 3213 and thepressure bar 3211, in some embodiments, may be replaceable. For example,massager wheel 3213 and the pressure bar 3211 may be clipped into theirplaces and may be replaced with new massager wheel 3213 and the pressurebar 3211 for each different subject.

Some embodiments may provide a tray or container that may include manydisposable test cartridges, each cartridge with a disposable adjustablelancet such as lancet 820 of FIGS. 32-37. In these embodiments, oncetaking blood sample from a subject is completed, the vial, receptacle,or microfluid system that has received the blood from the tube 3207 iselectronically labelled with the subject's information (e.g., name,patient identification number, etc.) and the associated disposablecartridge is removed. The same process is then repeated from the nextsubject.

FIGS. 38A-38B illustrate a flow chart of an exemplary process 3800 thatcontrols the adjustable lancet of FIGS. 32-37. Such a process may beexecuted by the SCTD 100. As shown, process 3800 may determine (at 3805)whether a finger is detected in the finger receptacle. For example, insome embodiments, the force sensor 3206 (FIG. 36) may detect an increasein the pressure applied to the force sensor 3206 by the fingerreceptacle 3201 when a subject's finger 3690 is placed in fingerreceptacle 3201. The process 3800 may compare an increase in the forcemeasured by the force sensor with a range of increases in the force anddetermine that the measured increase in the force is attributed to afinger placed in the receptacle. In some other embodiments, the lightsource(s) 3635 and the light sensor(s) 3630 and/or the light source(s)3640 and the light sensor(s) 3645 may be used to detect the finger. Insome other embodiments, the process 3800 may receive a signal indicatinga finger is in the finger receptacle when a button on the SCTD ispressed, when a signal is received from an external device, when poweris received at the adjustable lancet assembly, etc.

When a finger is not detected, the process 3800 may return to 3805 andmay repeat the operation 3805 until a finger is detected. Otherwise, theprocess 3800 may determine (at 3810) whether the finger is placed in thefinger receptacle with the fingertip towards the lancet. For example,the process may use the light source(s) 3635 and the light sensor(s)3630 and/or the light source(s) 3640 and the light sensor(s) 3645 ofFIG. 36 to determine whether the fingertip is toward the lancet (and thefingernail is away from the lancet). As described above with referenceto FIG. 36, the light source(s) may direct light to the finger and thelight reflected from the finger is then sensed by the light sensor(s).The sensed light may then be analyzed to determine whether thefingernail is facing opposite the lancet.

When the finger is not placed in the receptacle with the fingertiptowards the lancet, the process 3800 may generate (at 3815) a warningsignal. The process 3800 may then end. The warning signal may be eithera visual signal (e.g., a light turned on or off, a message displayed ona UI associated with the SCTD 100, etc.), may be an audible signal, maybe an electronic signal sent to a device outside the SCTD 100, etc.

When the finger is placed in the receptacle with the fingertip towardsthe lancet, the process 3800 may move (at 3820) the lancet housing by anincremental distance towards the finger receptacle. The process 3800 maythen determine (at 3825) whether the force sensor (e.g., the forcesensor 3206 of FIGS. 36-37) has indicated the lancet housing is touchingthe finger. For example, the process 3800 may determine that the lancethousing's protrusion 3240 is touching the finger 3690 based on theincrease in the resistance of the force sensor caused by the forceexcreted by the lancet housing 3202 to the finger 3690 and by the forceexcreted by the finger 3690 to the receptacle 3201. The process 3800 maycompare the increase in the force measured by the force sensor with arange of increases in the force and determine that the measured increasein the force is attributed to the lancet housing touching the finger.

When the process 3800 determines that lancet housing is not touching thefinger, the process 3800 may return to 3820, which was described above.Otherwise, the process 3800 may move (at 3830) the lancet housing back apredetermined distance (e.g., a few millimeters) to relieve the pressureon the finger. The process 3800 may then release (at 3840) the triggerhandle (e.g., the trigger handle 3204) to get the lancet 820 releasedand prick the finger.

The process 3800 may then swing (at 3845) the massager wheel (e.g., themassager wheel 3213) a predetermined number of times to massage thefingertip to draw additional blood. The process 3800 may also move (at3850) the pressure bar (e.g., the pressure bar 3211) back and forth apredetermined number of times to apply pressure to the finger to drawadditional blood.

The process 3800 may then start (at 3855) the pump connected to theblood collection tube (e.g., the tube 3207). The process 3800 may thenmove (at 3860) the tube down and forward in line with where the needlepricks the finger to collect blood. The process 3800 may then stop (at3865) the pump after a predetermined time period.

The process 3800 may then move (at 3870) the tube to a vial, a fluidreceptacle, or a microfluid system. The process 3800 may then reverse(at 3875) the pump to empty the blood from the tube into the vial, thereceptacle, or the microfluid system. The process 3800 may thendetermine (at 3880) whether the blood is withdrawn a specified number oftimes. If not, the process 3800 may proceed to 3845 to repeat operations3845-3880. Otherwise, the process 3800 may end. In the embodiments thatthe blood is drawn from the tube in a continuous operation, operation3880 may be skipped.

FIG. 39 illustrates a flow chart of an exemplary process 3900 thatprocesses a sample using the sample processing module 110 of FIG. 16.Such a process may be executed by the SCTD 100. The process may beginafter a sample is taken, such as described above in reference tooperation 2650 and process 2700.

As shown, process 3900 may fill (at 3910) a first cavity (e.g., cavity1640). Such a cavity may be filled using a first pump (e.g., pump 1620)and a first optical sensor (e.g., sensor 1610) to provide a specifiedamount of fluid to the cavity (e.g., cavity 1640). Some embodiments mayapply one thousand pulses, for example, to the pump in order to move onemicroliter of blood, with an accuracy of approximately one nanoliter.

In some embodiments, the optical sensor (e.g., sensor 1610) may beplaced before a pump (e.g., pump 1620) such that when fluid is detectedat the optical sensor, a stepper motor of the pump may be operated for anumber of pulses in order to move a defined amount of fluid. Such sensorplacement may result in improved accuracy by eliminating additionalfluid that may be retained past the pump and later pulled into theassociated cavity.

Next, the process may add (at 3920) a buffer solution. The buffersolution may be stored in a second cavity (e.g., cavity 1645) and movedinto the first cavity using a second pump (e.g., pump 1625). The secondpump may then be reversed and the mixture moved into the second cavity.Such operations may be performed over multiple iterations to thoroughlymix the solution.

The process may then separate (at 3930) the sample into halves (and/orother portion ratios). A third pump (e.g., pump 1630) and second opticalsensor (e.g., sensor 1635) may be used to accurately measure theappropriate amount of fluid (whether half or some other ratio) and movethat amount into a third cavity (e.g., cavity 1650), while retaining areference sample in the second cavity. The process may mix (at 3940)that sample with the contents of the third cavity. The third cavity mayinclude electrically charged (and/or otherwise tagged) HAAH antibodies(or any other appropriate antibody).

In addition, the second pump may be used to pump (at 3940) the referencehalf sample in the second cavity to the first measurement cavity (e.g.,cavity 1640). The third pump may move the mixture in the third cavitybetween the third cavity and the second cavity to thoroughly mix thesolution. At this point, any HAAH molecules in the blood sample willattach to the HAAH antibodies (or the target molecules will attach toother types of charged antibodies).

After mixing (at 3940) the sample with the antibodies, some embodimentsmay wait for a specified time to allow proper mixing of the sample andthe antibody to take place. The wait time may vary depending on variousrelevant factors (e.g., test type, temperature, accuracy needed, etc.).The wait time may be a programmable parameter of the SCTD 100.

Next, the process may mix (at 3950) the half sample in the third cavitywith the content of a fourth cavity (e.g., cavity 1655) using a fourthpump (e.g., pump 1635). The fourth cavity may include HAAH and magneticbeads that attach to any leftover HAAH antibodies that have not beenattached to HAAH molecules in the blood.

The process may then activate (at 3960) the electromagnet. Next, theprocess may use the fourth pump to move (at 3970) the contents of thethird cavity to the fourth cavity (or second measurement cavity),excluding the contents that are retained in the third cavity by theelectromagnet.

The process may then measure (at 3980) the charge difference between thecharge of the first cavity and the charge of the fourth cavity. Thedifference is proportional to the density of HAAH in the blood and maybe provided as the final output of the process. After providing (at3990) the results of the charge difference measurement, the process mayend.

In addition, the results and/or other parameters (e.g., opticalmeasurement waveforms, count values, subject information, testparameters, etc.) may be stored for future reference and analysis. HAAHmolecules (and HAAH antibodies) are described as one example only. Otherembodiments may utilize various other antibodies such that the densityof any target molecules in a sample may be determined.

FIG. 40 illustrates a flow chart of an exemplary process 4000 thatprocesses a sample using the sample processing module of FIG. 17. Such aprocess may be executed by the SCTD 100. The process may begin after asample is taken, such as described above in reference to operation 2650and process 2700.

As shown, process 4000 may move (at 4010) the sample to a first cavitysuch as cavity 1640. Such a sample may be collected via samplecollection element 1605 and pump 1620. The operations of the pump may beat least partly controlled based on data provided from a measurementelement such as element 1610. The first cavity may be pre-filled with abuffer solution.

Next, the process may mix (at 4020) the sample and buffer solution witha CL agent attached to an antibody (e.g., CL attached to HAAH antibody).A second cavity, such as cavity 1645, may be pre-filled with suchantibodies. A pump such as pump 1625 may be used to mix the contents ofthe first and second cavities by moving the mixture between the cavitiesseveral times.

The process may then mix (at 4030) the sample with the complementarymolecule attached to magnetic beads such as those described above (e.g.,HAAH protein attached to magnetic beads). A third cavity (e.g., cavity1650) may be pre-filled with such a solution and the sample may be mixedusing pump 1630 to move the mixture between the second and thirdcavities.

Next, the process may activate (at 4040) the electromagnet (e.g., magnet1660) and then remove (at 4050) the non-magnetic portion of the samplemixture. The non-magnetic portion may be removed using pump 1630, forinstance, such that the non-magnetic portion (which includes the boundCL agents and antibodies) may be retained in the second cavity.

Finally, the process may measure (at 4060) the CL of the mixture in thesecond cavity and then may end. Such a measurement may be made using adetector such as detector 1700 described above. The measurement may beprovided to various appropriate resources, such as a processor, userdevice, etc. Likewise, the measurement may be provided by a UI 120 ofsome embodiments.

FIG. 41 illustrates a flow chart of an exemplary process 4100 thatprocesses a sample using the sample processing module 110 of FIG. 18.Such a process may be executed by the SCTD 100. The process may beginafter a sample is taken, such as described above in reference tooperation 2650 and process 2700.

As shown, process 4100 may collect (at 4110) a sample. Such a sample maybe collected via sample collection element 1810 using a first pump 1830,first and second measurement elements 1820, and a first cavity (C1)1840.

Next, the process may add (at 4120) a buffer solution to the sample. Thebuffer solution may be moved to the first cavity (C1) 1840 using asecond pump 1830, third and fourth measurement elements 1820, and apre-filled cavity (BS) 1850. As above, the solution may be moved betweencavity (BS) and cavity (C1) several times to thoroughly mix thesolution. Some portion of the mixture (usually 50%) may be retained insome embodiments (e.g., within cavity (C1)) for future analysis.

The process may then mix (at 4130) the mixture with electrically chargedantibodies by moving a portion (usually 50%) of the contents of cavity(C1) to cavity (C2) while also moving the contents of cavity (AB) intocavity (C2) as well. The pre-filled cavity (AB) may include suchantibodies, which may be mixed with the mixture of cavity (C1). Themixing of such elements may be performed using a combination of thepumps 1830, where some pumps may act as valves at any given time whileone or more pumps may be used to move the contents of various cavitiesalong the fluid pathway to other cavities.

Next, the process may mix (at 4140) the mixture in cavity (C2) with acertain agent or protein (e.g., HAAH protein) attached to magneticbeads. Pre-filled cavity (MB) may include such a magnetic solution. Themixture may be retained in cavity (C2). The process may then activate(at 4150) the electromagnet 1870 such that the magnetic beads (andassociated particles) are retained in the cavity (C2).

Process 4100 may then pump (at 4160) the non-magnetic portion of themixture in cavity (C2) to a third measurement cavity (C3). Next, theprocess may deactivate (at 4170) the magnet.

Finally, the process may measure (at 4180) the charge difference betweenthe first measurement cavity (C1) and the third measurement cavity (C3)and then may end. Alternatively, different embodiments may performvarious other measurements (e.g., charge, impedance or conductance, pHlevel, color or other visual attributes, and/or any other measurableattribute of the fluid).

The measured value may be provided to various appropriate resources,such as a processor 1320, user device 1310, etc.

One of ordinary skill in the art will recognize that processes 2600-4100are exemplary in nature and different embodiments may perform suchprocesses in various different ways. For instance, the variousoperations may be performed in different orders. As another example,some embodiments may include additional operations and/or omit variousoperations. Further, some embodiments may divide the processes intomultiple sub-processes and/or combine multiple processes into a macroprocess. Some operations, and/or sets of operations may be performediteratively, and/or based on some criteria other than those describedabove.

III. Computer System

Many of the processes and modules described above may be implemented assoftware processes that are specified as one or more sets ofinstructions recorded on a non-transitory storage medium. When theseinstructions are executed by one or more computational element(s) (e.g.,microprocessors, microcontrollers, digital signal processors (DSPs),application-specific integrated circuits (ASICs), field programmablegate arrays (FPGAs), etc.) the instructions cause the computationalelement(s) to perform actions specified in the instructions.

In some embodiments, various processes and modules described above maybe implemented completely using electronic circuitry that may includevarious sets of devices or elements (e.g., sensors, logic gates, analogto digital converters, digital to analog converters, comparators, etc.).Such circuitry may be able to perform functions and/or features that maybe associated with various software elements described throughout.

FIG. 42 illustrates a schematic block diagram of an exemplary computersystem 4200 used to implement some embodiments. For example, the systemand devices described above in reference to FIG. 1-FIG. 25 may be atleast partially implemented using computer system 4200. As anotherexample, the processes described in reference to FIG. 26-FIG. 41 may beat least partially implemented using sets of instructions that areexecuted using computer system 4200.

Computer system 4200 may be implemented using various appropriatedevices. For instance, the computer system may be implemented using oneor more personal computers (PCs), servers, mobile devices (e.g., asmartphone), tablet devices, and/or any other appropriate devices. Thevarious devices may work alone (e.g., the computer system may beimplemented as a single PC) or in conjunction (e.g., some components ofthe computer system may be provided by a mobile device while othercomponents are provided by a tablet device).

As shown, computer system 4200 may include at least one communicationbus 4205, one or more processors 4210, a system memory 4215, a read-onlymemory (ROM) 4220, permanent storage devices 4225, input devices 4230,output devices 4235, audio processors 4240, video processors 4245,various other components 4250, and one or more network interfaces 4255.

Bus 4205 represents all communication pathways among the elements ofcomputer system 4200. Such pathways may include wired, wireless,optical, and/or other appropriate communication pathways. For example,input devices 4230 and/or output devices 4235 may be coupled to thesystem 4200 using a wireless connection protocol or system.

The processor 4210 may, in order to execute the processes of someembodiments, retrieve instructions to execute and/or data to processfrom components such as system memory 4215, ROM 4220, and permanentstorage device 4225. Such instructions and data may be passed over bus4205.

System memory 4215 may be a volatile read-and-write memory, such as arandom access memory (RAM). The system memory may store some of theinstructions and data that the processor uses at runtime. The sets ofinstructions and/or data used to implement some embodiments may bestored in the system memory 4215, the permanent storage device 4225,and/or the read-only memory 4220. ROM 4220 may store static data andinstructions that may be used by processor 4210 and/or other elements ofthe computer system.

Permanent storage device 4225 may be a read-and-write memory device. Thepermanent storage device may be a non-volatile memory unit that storesinstructions and data even when computer system 4200 is off orunpowered. Computer system 4200 may use a removable storage deviceand/or a remote storage device as the permanent storage device.

Input devices 4230 may enable a user to communicate information to thecomputer system and/or manipulate various operations of the system. Theinput devices may include keyboards, cursor control devices, audio inputdevices and/or video input devices. Output devices 4235 may includeprinters, displays, audio devices, etc. Some or all of the input and/oroutput devices may be wirelessly or optically connected to the computersystem 4200.

Audio processor 4240 may process and/or generate audio data and/orinstructions. The audio processor may be able to receive audio data froman input device 4230 such as a microphone. The audio processor 4240 maybe able to provide audio data to output devices 4240 such as a set ofspeakers. The audio data may include digital information and/or analogsignals. The audio processor 4240 may be able to analyze and/orotherwise evaluate audio data (e.g., by determining qualities such assignal to noise ratio, dynamic range, etc.). In addition, the audioprocessor may perform various audio processing functions (e.g.,equalization, compression, etc.).

The video processor 4245 (or graphics processing unit) may processand/or generate video data and/or instructions. The video processor maybe able to receive video data from an input device 4230 such as acamera. The video processor 4245 may be able to provide video data to anoutput device 4240 such as a display. The video data may include digitalinformation and/or analog signals. The video processor 4245 may be ableto analyze and/or otherwise evaluate video data (e.g., by determiningqualities such as resolution, frame rate, etc.). In addition, the videoprocessor may perform various video processing functions (e.g., contrastadjustment or normalization, color adjustment, etc.). Furthermore, thevideo processor may be able to render graphic elements and/or video.

Other components 4250 may perform various other functions includingproviding storage, interfacing with external systems or components, etc.

Finally, as shown in FIG. 42, computer system 4200 may include one ormore network interfaces 4255 that are able to connect to one or morenetworks 4260. For example, computer system 4200 may be coupled to a webserver on the Internet such that a web browser executing on computersystem 4200 may interact with the web server as a user interacts with aninterface that operates in the web browser. Computer system 4200 may beable to access one or more remote storages 4270 and one or more externalcomponents 4275 through the network interface 4255 and network 4260. Thenetwork interface(s) 4255 may include one or more applicationprogramming interfaces (APIs) that may allow the computer system 4200 toaccess remote systems and/or storages and also may allow remote systemsand/or storages to access computer system 4200 (or elements thereof).

As used in this specification and any claims of this application, theterms “computer”, “server”, “processor”, and “memory” all refer toelectronic devices. These terms exclude people or groups of people. Asused in this specification and any claims of this application, the term“non-transitory storage medium” is entirely restricted to tangible,physical objects that store information in a form that is readable byelectronic devices. These terms exclude any wireless or other ephemeralsignals.

Each of the processes described herein, including the processes 2600,2700, 2800, 2900, 3000, 3100, 3800, 3900, 4000, and 4100 are illustratedas a collection of blocks in a logical flow graph, which represent asequence of operations that may be implemented in hardware, software, ora combination thereof. In the context of software, the blocks representcomputer-executable instructions stored on one or more computer-readablestorage media that, when executed by one or more processors, perform therecited operations. Generally, computer-executable instructions includeroutines, programs, objects, components, data structures, and the likethat perform particular functions or implement particular abstract datatypes. The order in which the operations are described is not intendedto be construed as a limitation, and any number of the described blocksmay be combined in any order and/or in parallel to implement theprocesses. Additionally, any number of the described blocks may beoptional and eliminated to implement the processes.

It should be recognized by one of ordinary skill in the art that any orall of the components of computer system 4200 may be used in conjunctionwith some embodiments. Moreover, one of ordinary skill in the art willappreciate that many other system configurations may also be used inconjunction with some embodiments or components of some embodiments.

In addition, while the examples shown may illustrate many individualmodules as separate elements, one of ordinary skill in the art wouldrecognize that these modules may be combined into a single functionalblock or element. One of ordinary skill in the art would also recognizethat a single module may be divided into multiple modules.

The foregoing relates to illustrative details of exemplary embodimentsand modifications may be made without departing from the scope of thedisclosure as defined by the following claims.

What is claimed is:
 1. A sample collection and testing device,comprising: a processor; a finger receptacle; a lancet housing; a lancetattached to the lancet housing; a set of one or more light sourcesconfigured to direct light to the finger receptacle; and a set of one ormore light sensors configured to measure light reflected from a person'sfinger positioned on the finger receptacle; wherein the processor isconfigured to: receive light measurements from the set of light sensors;determine, from the light measurements, whether the finger is placed inthe finger receptacle such that a fingernail is facing the lancet; andextend the lancet to prick the finger only when the finger is placed inthe finger receptacle such that no fingernail is facing the lancet. 2.The sample collection and testing device of claim 1, wherein a portionof the finger receptacle that touches the finger is transparent, whereinthe set of light sources direct light to the finger receptacle throughthe transparent portion of the finger receptacle.
 3. The samplecollection and testing device of claim 2, wherein the set of lightsensors receive the light reflected from the finger through thetransparent portion of the finger receptacle.
 4. The sample collectionand testing device of claim 2, wherein the transparent portion of thefinger receptacle is made of one of glass and clear plastic.
 5. Thesample collection and testing device of claim 1, wherein the set oflight sources and the set of light sensors are positioned on the lancethousing.
 6. The sample collection and testing device of claim 1, whereinthe processor is configured to generate a warning when the processordetermines that the finger is placed in the finger receptacle such thatthe fingernail faces the lancet.
 7. The sample collection and testingdevice of claim 1, wherein the set of light sources comprises at leastone of a light emitting diode (LED) light source, a laser, and a bulb.8. The sample collection and testing device of claim 1, wherein the setof light sensors comprises one or more photodetectors.
 9. The samplecollection and testing device of claim 1, wherein the lancet housing andthe lancet are in a disposable cartridge, and wherein the processor andthe finger receptacle are reusable for a plurality of disposablecartridges.
 10. The sample collection and testing device of claim 1,wherein the processor is configured to: move the lancet housing by anincremental distance; determine that the lancet housing has not touchedthe finger based on the force measurements received from a force sensor;repeat the moving of the lancet housing by an incremental distance untildetermining that the lancet housing has touched the finger based on theforce measurements received from the force sensor; and move the lancethousing away from the finger by a predetermined distance to relievepressure on the finger.
 11. The sample collection and testing device ofclaim 1 further comprising: a pressure bar; a shaft connected to thepressure bar; wherein the processor is configured to: move the lancethousing and the lancet away from the finger receptacle after the lancetis extended out of the lancet housing; and move the shaft back and forthone or more times to apply pressure to a side of the finger.
 12. Thesample collection and testing device of claim 1 further comprising: acap connected to the lancet housing, the cap comprising an opening forthe lancet to extend out of the lancet housing; and a cup connected tothe lancet, the cup located inside the lancet housing, wherein the cupis configured to reach the cap when the lancet is extended out of thehousing preventing the lancet to extend out of the housing more than apredetermined length.
 13. The sample collection and testing device ofclaim 1 further comprising: a release handle movable between an engagedposition and a disengaged position, the engaged position restrictingmovement of the lancet out of the lancet housing, and the disengagedposition allowing the movement of the lancet out of the lancet housing;wherein the processor is configured to move the release handle from theengaged position to the disengaged position to extend the lancet out ofthe lancet housing.
 14. The sample collection and testing device ofclaim 1 further comprising: a massager wheel; a shaft connected to themassager wheel; wherein the processor is configured to: move the lancethousing and the lancet away from the finger receptacle after the lancetis extended out of the lancet housing; and swing the shaft after movingthe lancet to make one or more contacts between the massager wheel andthe finger.
 15. An automated method of preventing a lancet of a samplecollection and testing device from pricking a fingernail, the samplecollection and testing device comprising a finger receptacle and a setof one or more light sources configured to direct light to the fingerreceptacle, the method comprising: by a processor of the samplecollection and testing device: receiving a signal indicating a person'sfinger is in the finger receptacle; prior to an extending of the lancetto prick the finger, receiving light measurements from a set of one ormore light sensors that are configured to measure light reflected fromthe finger placed in the finger receptacle; determining whether thefinger is placed in the finger receptacle such that a fingernail isfacing the lancet from the light measurements; and extending the lancetonly when the finger is placed in the finger receptacle such that nofingernail is facing the lancet.
 16. The automated method of claim 15,the sample collection and testing device comprising a lancet housing, amassager wheel, and a shaft connected to the massager wheel, the methodfurther comprising: by the processor of the sample collection andtesting device: moving the lancet housing and the lancet away from thefinger receptacle after the lancet is extended out of the lancethousing; and swinging the shaft after moving the lancet to make one ormore contacts between the massager wheel and the finger.
 17. Theautomated method of claim 15, the sample collection and testing devicecomprising a lancet housing, a pressure bar and a shaft connected to thepressure bar, the method further comprising: by the processor of thesample collection and testing device: moving the lancet housing and thelancet away from the finger receptacle after the lancet is extended outof the lancet housing; and moving the shaft back and forth one or moretimes to apply pressure to a side of the finger.
 18. The automatedmethod of claim 15, the sample collection and testing device comprisinga lancet housing, a release handle movable between an engaged positionand a disengaged position, the engaged position restricting movement ofthe lancet out of the lancet housing, and the disengaged positionallowing the movement of the lancet out of the lancet housing, themethod further comprising: moving, by the processor of the samplecollection and testing device, the release handle from the engagedposition to the disengaged position to extend the lancet out of thelancet housing.
 19. The automated method of claim 15, wherein the lancetis attached to an interior of a lancet housing of the sample collectionand testing device, the method further comprising: by the processor ofthe sample collection and testing device: moving the lancet housing byan incremental distance; determining that the lancet housing has nottouched the finger based on the force measurements received from a forcesensor of the sample collection and testing device; repeating the movingof the lancet housing by an incremental distance until determining thatthe lancet housing has touched the finger based on the forcemeasurements received from the force sensor; and moving the lancethousing away from the finger by a predetermined distance to relievepressure on the finger.
 20. The automated method of claim 15 furthercomprising, generating a warning by the processor of the samplecollection and testing device when the processor determines that fingeris placed in the finger receptacle such that the fingernail faces thelancet.